Method and apparatus for tooth regulation with heavy forces

ABSTRACT

Methods are provided for regulating tooth movement and for maintaining or improving tissue health using heavy forces. Such methods comprise allowing a heavy force to be exerted on one or more teeth of a patient in need thereof; and administering an effective amount of light to the maxillary or mandibular alveolar bone of the patient, wherein the light is administered before, during, or after the heavy force is exerted. The light can have a wavelength in the range of about 585 nm to about 665 nm, or about 815 nm to about 895 nm. An apparatus useful for providing light therapy is also provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/826,383, filed Mar. 14, 2013, which is a continuation of and claimspriority to International Patent Application No. PCT/CA2011/050639,filed Oct. 12, 2011, which claims the benefit of U.S. Provisional PatentApplication No. 61/392,809, filed Oct. 13, 2010, the disclosure of eachof which is incorporated by reference herein in its entirety.

FIELD OF INVENTION

This invention relates to methods and apparatuses useful inorthodontics, and in particular to methods and apparatuses useful forregulating tooth movement; reducing, preventing or minimizing tooth-rootresorption; reducing bone resorption or inflammatory dentin resorptionor cementum resorption of the tooth root or periodontium; preventing orminimizing inflammation of tissue surrounding one or more teeth uponwhich heavy forces are or were exerted; or regenerating maxillary ormandibular alveolar bone, using heavy forces.

BACKGROUND

Orthodontics involves the movement of teeth through bone. By applyingpressure to a tooth, bone can be broken down at a leading edge of thetooth to facilitate tooth movement. New bone is then created at atrailing edge of the tooth. Bone is resorbed in (e.g., broken down) inareas of pressure between a tooth root and periodontium, and bone isdeposited (created) in areas of tension between a tooth root andperiodontium. Pressure can cause resorption and tension can causedeposition regardless of where they occur along a tooth root surface.Movement of teeth through bone is slow based on the speed of theremodeling process while teeth are undergoing conventional orthodontictreatment, thereby necessitating treatments of long duration in order toachieve the desired tooth position. Long-term orthodontic treatment canhave an increased risk of root resorption, gingival inflammation anddental caries. Moreover, movement of teeth through bone can be uneven,as teeth might “tip” due to the force applied, i.e., the crown of thetooth can move in the desired direction more quickly than the root ofthe tooth, resulting in tipping of the tooth. When teeth move “bodily”through the bone (i.e., in a more or less perpendicular orientationrelative to the bone), the teeth move without tipping or with only a lowdegree of tipping.

Methods for increasing the rate of tooth movement without damage to thetooth and periodontium have been sought out. For example, accelerationof tooth movement can be produced by the local injection ofprostaglandins, the active form of vitamin D3, and osteocalcin aroundthe alveolar socket. These substances might increase the rate of toothmovement, but might also cause side effects such as local pain anddiscomfort for a patient during the process of injection.

An alternative strategy for increasing the rate of tooth movement is toimprove bone regeneration. For example, light therapy has been found tobe effective in the treatment of bone disorders and the biostimulationof bone and soft tissue, and can be effective in accelerating alveolarbone regeneration. Light can stimulate a variety of biologicalactivities in cells and tissues that are compromised in function, forexample, by stimulating cytochrome C oxidase or nitric oxide synthase.

Phototherapy or light therapy treatment is typically administered by aphysician or therapist who directs light from a hand-held light emittingapparatus at an affected area. Light emitting apparatuses can bedifficult to position consistently over the affected area. Sometimes atattoo is used to identify the affected area. However, even with atattoo or other reference mark it can be difficult to consistentlyadminister light therapy treatments to an affected area.

Light therapy typically involves repeated treatments over at leastseveral days. Thus, patients undergoing light therapy might be requiredto make multiple visits to a practitioner's office or clinic in order tocomplete a therapy regimen. Such repeated visits can be time consumingor expensive.

LEDs and other light emitters suitable for generating light for lighttherapy can get hot when they operate. Such light emitters can beinefficient at higher temperatures. Hot apparatuses can also beuncomfortable or even dangerous to patients.

Apparatuses for delivering light therapy to the dental and maxillofacialareas of a patient have been developed, for example as described in PCTpublication numbers WO 2009/000075 and WO 2006/087633, both of which arehereby incorporated by reference in their entirety. However, thereremains a need for light-therapy apparatuses that can deliverspecifically targeted light therapy to flood desired regions of apatient's jawbone with light having desired characteristics.

There further remains a need for methods and apparatuses that are usefulfor increasing the velocity or improving the quality of tooth movementthrough bone in response to orthodontic treatment, to decrease treatmenttimes for patients without undesirable side effects or pain. There isalso a need for methods and apparatuses that can be used to achieve adesired mode or quality of movement of teeth through the bone, e.g.,bodily movement of teeth through bone, and that are adjustable to permittooth movement to be modulated at a desired specific location orlocations within a patient's jaw region.

The foregoing examples of the related art and limitations relatedthereto are intended to be illustrative and not exclusive. Otherlimitations of the related art will become apparent to those of skill inthe art upon a reading of the specification and a study of the drawings.

SUMMARY OF THE INVENTION

An aspect of the invention relates to methods for regulating toothmovement, comprising allowing a heavy force to be exerted on one or moreteeth of a patient in need thereof; and administering an effectiveamount of light to the maxillary or mandibular alveolar bone of thepatient, wherein the light is administered before, during, or after theheavy force is exerted.

Another aspect of the invention provides methods for maintaining orimproving tissue health, comprising allowing a heavy force to be exertedon one or more teeth of a patient in need thereof; and administering aneffective amount of light to the maxillary or mandibular alveolar boneof the patient, wherein the light is administered before, during, orafter the heavy force is exerted.

Additional aspects and advantages of the present disclosure will becomereadily apparent to those skilled in this art from the followingdetailed description, wherein only illustrative embodiments of thepresent disclosure are shown and described. As will be realized, thepresent disclosure is capable of other and different embodiments, andits several details are capable of modifications in various obviousrespects, all without departing from the disclosure. Accordingly, thedrawings and description are to be regarded as illustrative in nature,and not as restrictive.

INCORPORATION BY REFERENCE

Each publication, patent, and patent application referenced in thisspecification is herein incorporated by reference in its entirety.

BRIEF DESCRIPTION OF THE DRAWINGS

Reference is now made to the following detailed description and theaccompanying drawings of which:

FIG. 1 is an isometric view of an embodiment of a light-therapyapparatus useful for providing light therapy to specified regions of apatient's maxillary or mandibular alveolar bone.

FIG. 2 is a front view of the embodiment shown in FIG. 1.

FIG. 3 is a top view of the embodiment shown in FIG. 1.

FIG. 4 is a right isometric view of the embodiment shown in FIG. 1.

FIG. 5 is a schematic cross-sectional view through a portion of a lightsource having a light emitter and a reflector.

FIG. 6 is a top view of a programmable controller for use with alight-therapy apparatus.

FIG. 7A is a partial cross-sectional view of a support arm of anembodiment of a light-therapy apparatus showing the engagement between atrack engaging ridge on a light source and a track formed in the supportarm.

FIG. 7B is a partial cross-sectional view of a support arm of anembodiment of a light-therapy apparatus showing the engagement between atrack engaging ridge on a heat sink and a track formed in the supportarm.

FIG. 8A shows a first view of a light-therapy apparatus in accordancewith another embodiment of the invention.

FIG. 8B shows another view of the light-therapy apparatus.

FIG. 8C shows an additional view of the light-therapy apparatus.

FIG. 8D provides another view of the light-therapy apparatus.

FIG. 9 is a view from the front side of an extra-oral light-therapyapparatus having an intra-oral tray, an extra-oral bridge, and left andright side extra-oral LED arrays.

FIGS. 9A, 9B and 9C are respectively a cross-section, a front sideelevation and a rear elevation of a light source having a cooling fan, aheat sink and two arrays of light emitters.

FIG. 10 is a right side view of the apparatus of FIG. 9 with the end ofthe extra-oral bridge attached to the extra-oral LED array.

FIG. 11 is a view from the front-left side of the extra-oral bridge,intra-oral tray and extra-oral LED array of FIG. 9.

FIG. 12 is a view from the rear right side of the extra-oral bridge,intra-oral tray and extra-oral LED array of FIG. 9.

FIG. 13 is a view from the left rear side of the extra-oral bridge,intra-oral tray and extra-oral LED array of FIG. 9 with the intra-oraltray detached.

FIG. 14 is a perspective view of a light-therapy apparatus according toan alternative embodiment in which an LED array is supported by ahead-set.

FIG. 15 is a side view of the light-therapy apparatus of FIG. 14.

FIG. 16 is a perspective view of a light-therapy apparatus according toanother alternative embodiment in which an LED array is supported by ahead-set.

FIG. 17 is a front view of at least one LED array, and a connectordetached from the head-set.

FIG. 18 is a front view of an external light-therapy apparatus havingtwo LED arrays, a hinge-like member, and an attaching means.

FIG. 19 is a cross-sectional view of an LED array mounted onto asubstrate.

FIG. 20 is a cross-sectional view of an LED array detached from thesubstrate.

DETAILED DESCRIPTION OF THE INVENTION

The term “about” as used herein in connection with a referenced numericindication means the referenced numeric indication plus or minus up to10% of that referenced numeric indication. For example, the language“about 50” units covers the range of 45 units to 55 units.

The term “surrounding” (or any variation thereof) as used herein meanswithin about one (1) centimeter of a target object. For example, in someembodiments, the tissue that surrounds a tooth can refer to the tissuewithin about 1 cm of the tooth. In some embodiments, the methodsdisclosed herein are useful for preventing or minimizing inflammationthat is within about 1 cm of a tooth.

The term “patient” as used herein refers to any living subject that canreceive medical treatment. A patient can be, for example, a mammal suchas a human. The patient can be an adult patient or a child patient. Insome embodiments, the patient can be a living subject that receiveslight treatment, e.g., light administered to the patient extra-orally orintra-orally. In some such embodiments, the patient currently wears anorthodontic appliance. In other embodiments, however, the patient hadworn, or previously wore, an orthodontic appliance prior to beingadministered with an effective amount of light transdermally ornontransdermally to a region of the patient's maxillary or mandibularalveolar bone. In yet other embodiments, the patient will wear anorthodontic appliance subsequent to being administered with an effectiveamount of light transdermally or nontransdermally to a region of thepatient's maxillary or mandibular alveolar bone.

Methods for Regulating Tooth Movement or for Maintaining or ImprovingTissue Health

In accordance with an aspect of the invention, methods are provided forregulating tooth movement, comprising allowing a heavy force to beexerted on one or more teeth of a patient in need thereof; andadministering to a patient in need thereof an effective amount of lightto a region of the patient's maxillary or mandibular alveolar bone,wherein the light is administered before, during or after the heavyforce is exerted. As is described in more detail herein, the light canbe administered transdermally from an extra-oral light source ornontransdermally from an extra-oral or intra-oral light source.

Other embodiments of the invention provide methods for reducing,minimizing or preventing tooth root resorption comprising allowing aheavy force to be exerted on one or more teeth of a patient in needthereof; and administering an effective amount of light to the maxillaryor mandibular alveolar bone of the patient, wherein the light isadministered before, during, or after the heavy force is exerted.

Methods for reducing bone resorption or inflammatory dentin or cementumresorption of the tooth root or periodontium are further provided inaccordance with another aspect of the invention. Such methods compriseallowing a heavy force to be exerted on one or more teeth of a patientin need thereof; and administering an effective amount of light to themaxillary or mandibular alveolar bone of the patient, wherein the lightis administered before, during, or after the heavy force is exerted.

Another aspect of the invention provides methods for preventing orminimizing inflammation of tissue surrounding one or more teeth uponwhich heavy forces are or were exerted, comprising allowing a heavyforce to be exerted on one or more teeth of a patient in need thereof;and administering an effective amount of light to the maxillary ormandibular alveolar bone of the patient, wherein the light isadministered before, during, or after the heavy force is exerted.

Another aspect of the invention provides methods for regeneratingmaxillary or mandibular alveolar bone, comprising allowing a heavy forceto be exerted on one or more teeth of a patient in need thereof; andadministering an effective amount of light to the maxillary ormandibular alveolar bone of the patient, wherein the light isadministered before, during, or after the heavy force is exerted.

Heavy Forces

The phrase “heavy force” as used herein refers to a force that rangesfrom about 150 grams of force to about 600 grams of force, and that isexerted on a tooth. For example, in some embodiments, a heavy force is aforce having a magnitude of greater than about 150 grams of force. Inother embodiments, a heavy force is a force having a magnitude ofgreater than or equal to about 175 grams of force, greater than or equalto about 190 grams of force, greater than or equal to about 200 grams offorce, greater than or equal to about 210 grams of force, greater thanor equal to about 225 grams of force, or greater than or equal to about250 grams of force. In other embodiments, a heavy force is a forcehaving a magnitude of less than or equal to about 300 grams of force,less than or equal to about 350 grams of force, less than or equal toabout 400 grams of force, less than or equal to about 450 grams offorce, less than or equal to about 500 grams of force, less than orequal to about 550 grams of force, or less than or equal to about 600grams of force. In other embodiments, the heavy force's lower range isabout 175 grams of force, about 190 grams of force, about 200 grams offorce, about 210 grams of force, about 225 grams of force or about 250grams of force. In other embodiments the heavy force's upper range isabout 300 grams of force, about 350 grams of force, about 400 grams offorce, about 450 grams of force, about 500 grams of force, about 550grams of force, or about 600 grams of force. In some embodiments, theheavy force ranges from about 200 grams of force to about 500 grams offorce. In other embodiments, the heavy force ranges from about 250 gramsof force to about 450 grams of force. In one embodiment, the heavy forceranges from about 150 grams of force to about 300 grams of force.

In some embodiments, a heavy force is exerted on one or more teeth ofthe patient. For example, a heavy force can be exerted on one or more ofthe patient's teeth before, during, or after being administered with aneffective amount of light to a region of the patient's maxillary ormandibular alveolar bone. In other embodiments, however, a force that isless than a heavy force is exerted on one or more of a patient's teeth.In this embodiment, the force has a magnitude of less than 150 grams offorce, for example, a magnitude of about 100 grams of force or about 125grams of force.

The phrase “magnitude of heavy force” as used herein refers to theamount of force exerted per tooth. Alternatively, the “magnitude ofheavy force” can refer to the amount of force exerted on a plurality ofteeth. The magnitude of force exerted per tooth in the latter instanceis the total magnitude of force divided by the number of teeth. Forexample, if about 300 grams of force are exerted on to two teeth, thenthe force exerted on each tooth is about 150 grams. The phrase “gram offorce” as used herein refers to a unit of force equal to the magnitudeof force exerted on one gram of mass by a force of 9.80665 m/s² (i.e.,standard gravity). In some embodiments, the magnitude of heavy force isa gram of force that is exerted on a tooth. In other embodiments, themagnitude of heavy force is a gram of force that is exerted on aplurality of teeth.

In some embodiments, a heavy force is a force of sufficient magnitude tocause at least some amount of root resorption. In some embodiments, aheavy force has sufficient magnitude to have pathophysiological effects,to create a hyalinized zone or tissue death, to cause cell death, or tocause tissue inflammation when the heavy force is exerted without anyother form of treatment, such as light treatment. The heavy force can bean excessive pathophysiological force. A pathophysiological force maycause necrosis or root resorption. The heavy force can also causepressure on the periodontium that can result in ischemia, decreasedblood flow, or cell death.

A heavy force can be exerted on a tooth in any suitable manner. Forexample, in some embodiments, the heavy force is exerted normal (e.g.,orthogonal or at a 90 degree angle) relative to a side of one or moreteeth. In some embodiments, the heavy force is exerted at an anglerelative to a side of one or more teeth. For example, the heavy forcecan be exerted at an angle of about 45 degrees, about 60 degrees, about70 degrees, about 75 degrees, about 80 degrees, about 85 degrees, about90 degrees, about 95 degrees, about 100 degrees, about 105 degrees,about 110 degrees, about 120 degrees, or about 135 degrees relative to aside of one or more teeth. A heavy force can be exerted normal (e.g.,orthogonal or at a 90 degree angle) to, downwards to, or upwards to oneor more teeth at any angle. In some embodiments, a heavy proximal forceis applied to one or more teeth. In some other embodiments, a heavydistal force is applied to one or more tooth. In some embodiments, theheavy force is coronal pressure, e.g., a pressure exerted in thedirection of or on the crown of the tooth, which is useful to intrudeteeth; in other embodiments, the heavy force is apical pressure, e.g., apressure exerted in the direction of or on the root, which is useful toextrude teeth. In some embodiments, a heavy force is exerted on a mesial(e.g., side of tooth towards front of mouth) side of the tooth. In someembodiments, a heavy force is exerted on a distal, e.g., side of toothtowards back of mouth) side of the tooth. A heavy force can be exertedon a buccal, e.g., side of tooth towards cheek, side of the tooth, or aheavy force can be exerted on a lingual, e.g., side of tooth towardstongue) side of the tooth. A heavy force can be exerted on an occlusalsurface of a tooth. A heavy force can be exerted on an incisal surfaceof a tooth. A heavy force can be exerted on a proximal surface of atooth, e.g., mesial or distal surfaces in between teeth. A heavy forcecan be exerted on an apical,e.g., toward a root end, surface of a tooth.

A heavy force may be directed to push one or more teeth toward oneanother. A heavy force may be directed to push one or more teeth apart.A heavy force may be directed to move one or more teeth toward a side.In some embodiments, a heavy force may shift a tooth sideways along amaxilla or mandible. Alternatively, a heavy force may move a toothforwards or backwards relative to a maxilla or mandible.

In some embodiments, a heavy force is exerted at any point or regionalong a side of one or more teeth. In some embodiments, a heavy force isexerted at or near the top of one or more teeth, i.e., the side of atooth opposite its root or roots. In some embodiments, a heavy force isexerted at or near the middle of the clinical crown, e.g., exposed tothe air, above the gums, of one or more teeth. In other embodiments, aheavy force is exerted at or near the bottom of the clinical crown ofone or more teeth, i.e., the clinical crown of a tooth closer to itsroot. In some embodiments, the heavy force is applied to the root of theone or more teeth. A heavy force can be exerted on one or more of thepoints or regions described above on one or more teeth. In someembodiments, a heavy force is exerted along the side of the tooth.Depending on where or for how long the heavy force is exerted, some orno tipping may occur to the tooth. Tipping is described in more detailbelow.

In some embodiments, a heavy force can increase the velocity of toothmovement relative to where no force or where a lighter force is exerted.In these embodiments, in other words, the heavy force reduces the amountof time it takes for the tooth to move to its desired position withinthe gum. Exertion of a heavy force on one or more of a patient's teeth,particularly where the patient is administered with an effective amountof light to his or her maxillary or mandibular alveolar bone, canfurther reduce the amount of time of orthodontic treatment that apatient might undergo.

In some embodiments, a heavy force is exerted on one or more teeth of apatient by one or more orthodontic appliances. Accordingly, in oneembodiment, an orthodontic appliance can exert a heavy force on one ormore of the patient's teeth to facilitate tooth movement. Orthodonticappliances are described in more detail below. In some embodiments, theorthodontic appliance can be present on one or more of the patient'steeth. In some embodiments, the patient wears two or more orthodonticappliance and less than all of these appliances exert a heavy force onone or more of the patient's teeth. For example, the orthodonticappliance can exert a heavy force on only one tooth of the patient or,alternatively, the orthodontic appliance can exert a heavy force on aplurality of teeth of the patient. In another embodiment, theorthodontic appliance can selectively exert a heavy force on less thanall the teeth of the patient.

In some embodiments, an orthodontic appliance can be used for externalanchorage, and can be the form of a temporary anchorage device or in theform of headgear. For example, a patient that wears a first orthodonticappliance for an extended period of time, e.g., 2 years, canconcurrently wear a second orthodontic appliance, e.g., in the form ofheadgear, for temporary period of time, e.g., at night. The externallyworn headgear can physically or electronically communicate with thefirst orthodontic appliance to facilitate tooth movement as well as toprovide an external anchorage for the first orthodontic appliance.External anchorage can be used to facilitate the exertion of heavyforces to prevent untoward movement of anchorage teeth during use ofheavy forces.

As is described in more detail below, the patient can wear anorthodontic appliance subsequent to initiating the administration oflight. For example, the patient can wear an orthodontic appliance afterone or more light treatment sessions are completed. In this manner, aheavy force can be exerted on one or more teeth of the patient by theorthodontic appliance(s) subsequent to initiating the administration oflight. In some embodiments, however, a heavy force is exerted on one ormore teeth of the patient during the administration of light. In such anembodiment, the patient wears an orthodontic appliance while receivingthe light treatment. In other embodiments, a heavy force is exerted onone or more teeth of the patient prior to initiating the administrationof light. The patient, for example, could wear her orthodontic appliancefor any length of time before beginning the light treatment.

In some instances, heavy forces can cause a periodontal ligament tocompress, which can eventually lead to ischemia or cell death. Toprevent ischemia or eventual cell death, the heavy force is exerted withthe light treatment as described above. In one embodiment, however, theheavy force is exerted after the light treatment has started. In someembodiment, the heavy force is exerted minutes, hours, or days afterlight treatment has started. In this manner, the light treatment canprovide additional adenosine-5′-triphosphate (ATP) energy to tissuecells that will become stressed and could potentially become ischemic asa result of the heavy force. Illustrative frequencies of light treatmentare described herein. In some embodiments, the heavy force is exertedconcurrently with administration of light. In other embodiments, theheavy force is exerted subsequent to administration of light.

As described above, a heavy force can be exerted on one of more teethfrom any direction. More particularly, in some embodiments, the forcepushes two or more teeth together or apart, or pushes one or more teethto one side or area of a patient's mouth. For example, in someembodiments, the force can push two or more teeth toward the front ofthe patient's mouth, to the back of the patient's mouth, to the left ofthe patient's mouth, or to the right of the patient's mouth.

The phrase “regulating tooth movement” as used herein refers to andincludes one or more of the following functions and/or operations. Forexample, regulating tooth movement can include controlling the positionof one or more teeth relative to a supporting tissue. Regulating toothmovement can also include controlling (e.g., increasing, decreasing,maintaining) the velocity of tooth movement relative to a supportingtissue. For example, regulating tooth movement can include increasingthe velocity, or speed, of tooth movement. Regulating tooth movement canalso include controlling (e.g., increasing, decreasing) bodily movement,e.g., less tipping, more tipping, of one or more teeth. Regulating toothmovement can comprise moving one or more teeth bodily. “Bodily” movementoccurs when the tooth movement is generally perpendicular to the bone;“tipping” occurs when the crown or coronal region of the tooth movesmore quickly than the root or apical region of the tooth. Bodily toothmovement can include moving a tooth without causing significant tippingof the tooth. By “significant tipping” is meant that about 20% of thetooth does not move in the same lateral direction as the remaining about80%; in another embodiment about 10% of the tooth does not move in thesame lateral direction as the remaining about 90%; in another embodimentabout 5% of the tooth does not move in the same lateral direction as theremaining about 95%. Tooth movement can include lateral displacement ofone or more teeth. Regulating tooth movement can include inducing thetilting or tipping one or more teeth, minimizing or preventing thetilting or tipping one or more teeth, or maintaining an alignment ororientation of the one or more teeth. Regulating tooth movement can alsoinclude stabilizing tooth movement. In some instances, regulating toothmovement can include causing one or more teeth to maintain theirposition. In some embodiments, regulating tooth movement can include acombination of causing the displacement of one or more teeth and causingone or more other teeth to maintain their position.

Administering Light Treatment

Light can be administered to the patient in any of the following ways.The act or process of administering light is also referred to herein as“light treatment”. These terms are used interchangeably herein but areintended to have similar meanings unless otherwise stated.

Light can be administered to a region of the patient's maxillary ormandibular alveolar bone, or other region of the patient. In someembodiments, the light can be directed to one or more regions of apatient. The region can be within the patient's mouth. Some examples ofthese regions include, but are not limited to, one or more teeth (e.g.,incisor, canine, premolar, or molar, such as a maxillary centralincisor, maxillary lateral incisor, maxillary canine, maxillary firstpremolar, maxillary second premolar, maxillary first molar, maxillarysecond molar, maxillary third molar, mandibular central incisor,mandibular lateral incisor, mandibular canine, mandibular firstpremolar, mandibular second premolar, mandibular first molar, mandibularsecond molar, or mandibular third molar), a root of one or more teeth(e.g., wherein a root of a tooth may include a portion of one or moreroots supporting the tooth, one root supporting the tooth, a pluralityof roots supporting the tooth, or all of the roots supporting thetooth), tissue supporting one or more teeth, a portion of the maxilla(e.g., portion of the patient's maxillary alveolar bone), a portion ofthe mandible (e.g., portion of the patient's mandibular alveolar bone),alveolus, basal tissue, gingiva, periodontal ligaments, cementum,periodontium, a region of a jaw bone or tissue, or at least a portion ofthe patient's other oral soft tissue or bone tissue. The region can belocated on a left side or right side of the patient's face. In someembodiments, one or more regions are located on both the left and rightside of the patient's face. In some embodiments, the region can belocated on the front side of the patient's face. The region can includeone, two, three, four, five, six, seven, eight, or more teeth, or tissuesurrounding or supporting the teeth. The region can include one or moreroots of one, two, three, four, five, six, seven, eight, or more teeth,or periodontium of teeth. Regions can include tissue (e.g., alveolar orbasal tissue) surrounding or supporting any of the teeth specificallydescribed with or without including the tooth itself. Regions caninclude teeth or tissue supported by the maxilla or teeth supported bythe mandible. One or more regions can be adjacent to one another,continuous with one another, or separate from one another. Anydescription herein of regions or examples of regions can apply to anyother region or examples of treatment regions provided herein.

In some embodiments, light can irradiate a region that can include aportion of tissue (e.g., bone tissue, or soft tissue) or other regionswithin the patient's oral cavity without irradiating one or more otherportions of the patient's oral cavity. For example, light can irradiatethe mandibular first molar on the right side of the patient's oralcavity without irradiating the mandibular third molar that is alsolocated on the right side of the patient's oral cavity. In someembodiments, light is administered to one or more roots of only onetooth root and to only one periodontium. Alternatively, light isadministered to one or more roots of a plurality of teeth and to aplurality of periodontia. Light can be administered to one or more rootsof all or less than all the teeth and periodontia in the patient's oralcavity. One or more selected teeth, roots or periodontia can beirradiated with light. For example, the mandibular first molar and themandibular third molar on the right side of the patient's oral cavitycan be irradiated without the mandibular second molar being irradiated.

In some embodiments, light can irradiate a region that can include aportion of tissue (e.g., bone tissue, or soft tissue) or other regionswithin the patient's oral cavity at a much greater intensity than itirradiates other portions of the patient's oral cavity. For example,light can irradiate a first region at an intensity that is 3×, 5×, 10×,20×, 50×, or 100× greater than the intensity that irradiates any otherregion or portion of the patient's oral cavity. In one embodiment, lightcan irradiate a portion of a patient's maxillary or mandibular alveolarbone at a greater intensity than that of light that irradiates any ofthe patient's teeth. In another embodiment, light can irradiate or befocused with a greater intensity on the one or more teeth upon whichheavy forces are applied (that are desired to be moved), relative to theone or more teeth on which heavy forces are not exerted. Teeth withlower forces or anchorage teeth can be selectively shielded from lightor irradiated at lower light intensity so that they can move less andthe anchorage effect can be enhanced. In some embodiments, this isachieved by applying to the patient, or adjusting within the patient,one or more intra-oral or extra-oral light-translucent or light-opaquemasks that shield from light one or more non-regions. In someembodiments, light reaching a region can have an intensity that isgreater than a threshold value. In some embodiments, the threshold valuecan have an intensity as described elsewhere herein.

In some embodiments, the region can be close to a surface within thepatient's mouth, or within a soft tissue or bone tissue. The region canbe at a depth from the surface of the patient's face. For example, theregion can be about 1 m, about 1 m, about 10 m, about 50, about 100 m,about 200 am, about 300 m, about 500 am, about 750 jm, about 1 mm, about2 mm, about 3 mm, about 4 mm, about 5 mm, about 7 mm, about 10 mm, about15 mm, about 20 mm, about 25 mm, about 30 mm, about 40 mm, about 50 mm,about 60 mm, or about 70 mm from the surface of the patient's face.Light can irradiate a region, which can have an area greater than, lessthan, or about 1 nm², about 1 μm², about 0.1 mm², about 0.2 mm², about0.3 mm², about 0.4 mm², about 0.5 mm², about 0.7 mm², about 1 mm², about10 mm², about 0.2 cm², about 0.5 cm², about 1 cm², about 2 cm², about 3cm², about 5 cm², about 7 cm², about 10 cm², about 15 cm², about 20 cm²,about 25 cm², about 30 cm², about 35 cm², about 40 cm², about 50 cm², orabout 60 cm². Light can irradiate one area, a plurality of areas, apoint, or a plurality of points. In some embodiments, light canirradiate a particular area without irradiating with significantintensity surrounding areas. For example, light can irradiate a portionof jawbone without significant amounts of light irradiating teeth onthat jawbone. In another embodiment, light can irradiate a particulartooth or set of teeth without significant amounts of light irradiatingadjacent teeth. In one embodiment, irradiating a tooth includesirradiating an exposed surface of the tooth, a tooth root, or aperiodontium of the tooth.

In some embodiments, light can be administered extra-orally to thepatient. In some embodiments, light can be provided from a light-therapyapparatus, embodiments of which are described below. Light can beemitted from a light source that can include characteristics, features,components, or configurations of any of the light-therapy apparatusembodiments, as described below. A method for regulating tooth movementcan further comprise providing a light-therapy apparatus. The method forregulating tooth movement can also further comprise administering lightfrom a light-therapy apparatus. Light can be provided from any othersource, and is not limited to a light-therapy apparatus as describedherein.

Light administered extra-orally can include or refer to lightadministered from outside the patient's face. In some embodiments, lightcan be provided from a light source that can contact the patient's face,e.g., the stratum corneum of the patient's face. Similarly, light can beemitted from a plurality of light sources that can contact the patient'sface. In one embodiment, one or more light sources can contact skin ofthe patient's face overlying a region. Light can be administered from alight source that can provide pressure on the patient's face. Light canpass through the patient's face to irradiate the region. The region canbe located within a patient's oral cavity. In some embodiments, a lightemitter can be provided externally to the oral cavity. A portion of apatient's face, such as the cheek, skin over the jaw, lips, or chin canbe located between the light emitter and the oral cavity. Light can beadministered transcutaneously to a region that is located within thepatient's oral cavity. The light can transcutaneously pass through theskin of the patient to irradiate the region. Light can pass through thecheek of the patient, the skin overlying the jaw of the patient, thechin of the patient, the lips of the patient, or any other regioncircumscribed or otherwise defined by the patient's face. In someembodiments, light can irradiate a region by manually retaining one ormore light sources providing light of one or more wavelengths to one ormore regions of a patient. In some embodiments, light can irradiate aregion only transdermally through the skin of the patient. In someembodiments, light is administered only extra-orally, and is notadministered intra-orally. In some alternate embodiments, light can beadministered intra-orally or extra-orally. In one embodiment the patientto whom the light is administered has his or her mouth closed.

In other embodiments of extra-orally administered light, the lightsource does not contact the patient's face. For example, extra-orallight can be administered to the patient wherein a gap exists between alight source and skin of the patient's face. The light source can be inclose proximity to the skin of the patient's face without contacting thepatient's face. In some embodiments, light can be administered from alight source that does not contact a patient's face when the patient'sface is relaxed but can contact the face if the patient flexes a portionof the patient's face or tenses the face. In some embodiments, a lightsource is about 1 mm or less, about 2 mm or less, about 3 mm or less,about 5 mm or less, about 7 mm or less, about 1 cm or less, about 1.5 cmor less, about 2 cm or less, about 2.5 cm or less, or about 3 cm or lessaway from a patient's face while the patient's face is relaxed ortensed. Light can be emitted from a light source located at a particulardistance from a region. In some embodiments the distance is about 0.1 mmor less, about 0.5 mm or less, about 1 mm or less, about 2 mm or less,about 3 mm or less, about 5 mm or less, about 7 mm or less, about 1 cmor less, about 1.5 cm or less, about 2 cm or less, about 2.5 cm or less,or about 3 cm or less. In some embodiments, a light source is about 0.1mm, about 0.5 mm, about 1 mm, about 3 mm, about 5 mm, about 7 mm, about1 cm, about 1.5 cm, about 2 cm and about 2.5 cm, about 2.75 cm, about 3cm, about 3.5 cm, or about 4 cm away from the region to be treated by orirradiated by an effective amount of light.

In some embodiments, light is administered intra-orally to the patient.For example, the light source may be located within the patient's oralcavity. In some embodiments, light is administered directly, i.e.,nontransdermally, to a selected region or to a surface overlaying theselected region. In some embodiments, light is administered to aselected region through the patient's gums or soft tissue. Light neednot be applied transdermally or through the patient's face. In someembodiments, the light source may contact the selected region or surfaceoverlying the selected region. For example, the light source may contacta patient's tooth or gum.

Extra-oral or intraoral light can be administered from a single lightsource. Alternatively, light can be administered from multiple lightsources. Light can irradiate a continuous region or one or more discreteregions. Light can irradiate various regions from different directions.For example, light can be administered from a right side of a patient'sface and from a left side of a patient's face. Light can be administeredso that it is angled upward toward a region, or can be administered sothat it is angled downward to toward a region. In some embodiments,light can be administered from one or more stationary sources. Forexample, a light source can remain stationary during administration. Insome embodiments, light can be administered from one or more movinglight sources. A light source can be displaced, can be angled, can berotated, or any combination thereof. Light can be administered from acontinuously moving source, or can be administered from a discretely orabruptly moving source.

As described above, an effective amount of light can be administered. Aneffective amount of light is an amount of light that, when administeredbefore, during or after exertion of a heavy force on one or more of apatient's teeth, is effective for regulating tooth-movement; reducing,preventing or minimizing tooth-root resorption; reducing boneresorption, inflammatory dentin resorption or cementum resorption;preventing or minimizing inflammation of tissue surrounding one or moreteeth upon which heavy forces are or were exerted; or regeneratingmaxillary or mandibular alveolar bone. The light's properties caninclude, but are not limited to: its intensity, wavelength, coherency,range, peak wavelength of emission, energy density, continuity, pulsing,duty cycle, frequency or duration.

In some embodiments, a method for regulating tooth movement can furthercomprise determining an effective dosage of light. The determination canbe based on an intended tooth movement regulation effect. The method canfurther comprise selecting one or more light properties to provide theeffective dosage of light. The method can further comprise receivinginstructions from a controller, and emitting light having particularproperties. The controller can be any controller described herein or canimplement any of the steps described herein.

Light can be administered from one or more light source capable ofirradiating light having intended properties. A light source can emitlight from one or more light emitters. In some embodiments, a lightsource comprises about 10 to about 15 emitters, about 15 to about 20emitters, about 20 to about 30 emitters, about 30 to about 40 emitters,about 40 to about 50 emitters, about 50 to about 70 emitters, or about70 emitters to about 100 emitters. For example, light can beadministered from a light source, which can comprise one or more of thefollowing emitters: a light-emitting diode (LED), which can be presentin an array; and a laser, for example a vertical cavity surface emittinglaser (VCSEL) or other suitable light emitter such as anIndium-Gallium-Aluminum-Phosphide (InGaAIP) laser, a Gallium-ArsenicPhosphide/Gallium Phosphide (GaAsP/GaP) laser, or aGallium-Aluminum-Arsenide/Gallium-Aluminum-Arsenide (GaAIA5/GaAs) laser.In one embodiment the light source comprises a plurality of lasers. Aplurality of light emitters can emit light at one or more differentwavelengths. Alternatively, one or more light emitters can emit light atthe same wavelength for a light source. One or more light emitters canbe arranged on a light source in any manner, such as a linear array oranother arrangement described herein.

An effective amount of light can have an intensity that is effective forregulating tooth movement. In one embodiment, the light intensity is atleast about 10 mW/cm². In other embodiments, the light intensity isabout 1 mW/cm² or greater, about 3 mW/cm² or greater, about 5 mW/cm² orgreater, about 7 mW/cm² or greater, about 12 mW/cm² or greater, about 15mW/cm² or greater, about 20 mW/cm² or greater, about 30 mW/cm² orgreater, about 50 mW/cm² or greater, about 75 mW/cm² or greater, about100 mW/cm² or greater, about 200 mW/cm² or greater, about 500 mW/cm² orgreater, or about 1 W/cm² or greater. In other embodiments, the lightintensity is about 20 mW/cm² or less, about 30 mW/cm² or less, about 50mW/cm² or less, about 75 mW/cm² or less, about 100 mW/cm² or less, about200 mW/cm² or less, about 500 mW/cm² or less, about 1 W/cm² or less,about 2 W/cm² or less, about 5 W/cm² or less, or about 10 W/cm² or less.In one embodiment the light intensity ranges from about 1 mW/cm² toabout 10 W/cm². In another embodiment, the light intensity's lower rangeis about 3 mW/cm², about 5 mW/cm², about 7 mW/cm², about 12 mW/cm²,about 15 mW/cm², about 20 mW/cm², about 30 mW/cm², about 50 mW/cm²,about 75 mW/cm², about 100 mW/cm², about 200 mW/cm², about 500 mW/cm²,or about 1 W/cm². In another embodiment, the light intensity's upperrange is about 20 mW/cm², about 30 mW/cm², about 50 mW/cm², about 75mW/cm², about 100 mW/cm², about 200 mW/cm², about 500 mW/cm², about 1W/cm², about 2 W/cm², about 5 W/cm², or about 10 W/cm². Light can beadministered having an intensity falling within a range determined byany of the intensities mentioned above. In some embodiments theintensity is an average intensity. In some embodiments, the light has anintensity in the range of about 10 mW/cm² to about 60 mW/cm², or about20 mW/cm² to about 60 mW/cm². In such embodiments, the peak lightintensity can about 50 mW/cm² or greater. A peak wavelength is thewavelength at which the highest intensity of light is emitted. In someembodiments, light can be pulsed. In other embodiments, the output oflight is continuous. In some embodiments, the light intensity can varyover time in a cyclical or non-cyclical fashion. The light intensity canvary with or without pulsing. In some embodiments, pulse widthmodulation can be used to effect a desired light intensity. If one ormore wavelengths of light are administered, then each wavelength can beadministered at its own intensity. Additional details regardingeffective amounts or dosages of light are described below.

In some embodiments, an effective amount of light can include lighthaving a wavelength that is within in a particular range, or light of arange of wavelengths. The light is not necessarily visible light. Forexample, the light can include infrared light or near-infrared light.The light can also be provided in the visible light region. Light can beadministered having one or more wavelengths ranging from about 620 nm toabout 1000 nm. In some embodiments, administered light has one or morewavelengths ranging from about 585 nm to about 665 nm, about 815 nm toabout 895 nm, about 640 nm to about 680 nm, or about 740 nm to about 780nm, or any given wavelength or range of wavelengths within those ranges,such as, for example, about 625 nm or about 855 nm, or about 605 nm toabout 645 nm, or about 835 nm to about 875 nm. In some embodiments, theadministered light has one or more wavelengths from about 605 nm toabout 645 nm, or from about 835 nm to about 875 nm. In some embodiments,the administered light has one or more wavelengths from about 615 nm toabout 635 nm, or from about 845 nm to about 865 nm. In some embodiments,the wavelengths of the administered light can be about 625 nm or about855 nm. In additional embodiments, the administered light has one ormore wavelengths ranging from about 400 nm to about 1200 nm. Inparticular embodiments, the administered light has one or morewavelengths ranging from about 500 nm to about 700 nm, about 585 nm toabout 665 nm, about 605 nm to about 630 nm, about 620 nm to about 680nm, about 815 nm to about 895 nm, about 820 nm to about 890 nm, about640 nm to about 680 nm, or about 740 nm to about 780 nm. In someembodiments the administered light has one or more wavelengths in one orboth of the following wavelength ranges: about 820 to about 890 nm andabout 620 to about 680 nm. In some embodiments, the administered lighthas one or more wavelengths in the ranges of about 820 to about 890 nmand about 620 nm to about 680 nm. In some embodiments, the administeredlight has one or more wavelengths in the ranges of about 815 to about895 nm and about 585 to about 665 nm. The administered light canalternatively have one or more wavelengths in one or more of thefollowing ranges: about 613 nm to about 624 nm, about 667 nm to about684 nm, about 750 nm to about 773 nm, about 812 nm to about 846 nm. Inone embodiment, the light intensity's lower range is about 400 nm, about450 nm, about 500 nm, about 550 nm, about 585 nm, about 595 nm, about605 nm, about 613 nm, about 615 nm, about 620 nm, about 624 nm, about625 nm, about 640 nm, about 650 nm, about 667 nm, about 680 nm, about710 nm, about 740 nm, about 750 nm, about 770 nm, about 812 nm, about815 nm, about 820 nm, about 835 nm, about 845 nm, or about 860 nm. Inanother embodiment, the light intensity's upper range is about 585 nm,about 605 nm, about 624 nm, about 630 nm, about 635 nm, about 645 nm,about 655 nm, about 660 nm, about 665 nm, about 680 nm, about 684 nm,about 700 nm, about 725 nm, about 755 nm, about 773 nm, about 780 nm,about 795 nm, about 815 nm, about 830 nm, about 846 nm, about 855 nm,about 865 nm, about 875 nm, about 890 nm, about 895 nm, about 935 nm,about 975 nm, about 1000 nm, about 1050 nm, about 1100 nm, or about 1200nm.

In some embodiments, light is administered at one, two, or more of thelight ranges described. In some instances, light is not administeredoutside of one, two, or more of the light ranges described. In otherembodiments, administered light has other wavelengths, as desired for aparticular application. In some embodiments, light having a first set ofcharacteristics (e.g., wavelength, intensity, pulsing, timing) can beadministered to a first region, and light with a second set ofcharacteristics can be administered to a second region. The first regionand the second region can be the same region, can partially overlap, orcan not overlap. The first set of characteristics can be the same as thesecond set of characteristics, can partially overlap with the secondset, or can all be different from the second set. In one embodiment, oneregion of a jaw can receive light within a first wavelength range, whileanother region of the jaw can receive light within a second wavelengthrange. The first and second wavelengths can overlap. Alternatively, thefirst and second wavelengths do not overlap.

Although examples of light wavelength ranges are provided below fordifferent applications, light having any other light wavelength value,which can include those described above, can be administered for thoseapplications.

Extra-orally administering to a patient light having a wavelength in therange of about 815 nm to about 895 nm, such as about 835 nm to about 875nm, or about 855 nm, is useful in the present methods, in oneembodiment, for increasing the rate of movement of teeth. In anotherembodiment, intra-orally administering to a patient light having awavelength in the range of about 815 nm to about 895 nm, such as about835 nm to about 875 nm, or about 855 nm, is useful in the presentmethods, in one embodiment, for increasing the rate of movement ofteeth. In one embodiment increasing the rate of tooth movement does notincrease the tipping motion of teeth beyond that which is experienced byorthodontic patients who are not provided with light.

Extra-orally administering transdermally to a patient light having awavelength in the range of about 585 nm to about 665 nm, such as about605 nm to about 645 nm, or about 625 nm, is likewise useful in thepresent methods, in one embodiment, for increasing the rate of movementof teeth. In another embodiment, intra-orally administering to a patientlight having a wavelength in the range of about 585 nm to about 665 nm,such as about 605 nm to about 645 nm, or about 625 nm, is likewiseuseful in the present methods, in one embodiment, for increasing therate of movement of teeth.

In one embodiment administration of light having a wavelength in therange of about 585 nm to about 665 nm increases the amount or extent ofbodily tooth movement to a greater degree than administration with lighthaving a wavelength in the range of about 815 nm to about 895 nm.Administering light having a wavelength in the range of about 585 nm toabout 665 nm (e.g., about 625 nm) can result in about 10% to about 50%less tipping than the administration of light having a wavelength in therange of about 815 nm to about 895 nm (e.g., about 855 nm). For example,about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about40%, about 45%, or about 50% less tipping can occur. Particularwavelengths of light can minimize tipping.

Thus, in one embodiment administration of light having a wavelength inthe range of about 605 nm to about 645 nm, such as about 625 nm, isuseful in the present methods, in one embodiment, for facilitating thebodily movement of teeth in orthodontic treatment and optionallyincrease bone regeneration. In some embodiments the methods furthercomprise increasing bone regeneration. In another embodimentadministration of light having a wavelength in the range of about 835 toabout 875 nm, such as about 855 nm, is useful in the present methods, inone embodiment, for increasing the rate of movement of teeth for whichsome degree of tipping movement is desirable or acceptable andoptionally increasing bone regeneration.

In other embodiments administration of light having a wavelength in therange of about 605 nm to about 645 nm, such as about 625 nm, is usefulin the present methods, in one embodiment, for increasing the quality ordegree of bone remodeling. Accordingly the present invention furtherrelates to methods for increasing the quality or degree of boneremodeling, comprising allowing a heavy force to be exerted on one ormore teeth of a patient in need thereof and administering to a patientin need thereof an effective amount of light to a region of thepatient's maxillary or mandibular alveolar bone, or to other regions asdescribed herein. For example, light can be administered to regions oforal and maxillofacial bone or tissue.

Bone remodeling can include changes in any bone characteristic, such as,but not limited to, bone shape, bone volume, bone density, or bonemineral content. Increasing the quality or degree of bone remodeling canaid in increasing the retention of teeth in a particular position, forexample, in a position resulting from orthodontic treatment, such as anappliance of one or more orthodontic appliances, decreasing thepotential for teeth to move back to a previous position, for example, aposition prior to orthodontic treatment, such as any appliance of one ormore orthodontic appliances. Thus, administration of light having awavelength in the range of about 585 nm to about 665 nm, or about 605 nmto about 645 nm, or about 615 nm to about 635 nm, or about 625 nm,optionally also with light in the range of 815 nm to 895 nm, can beuseful in the present methods, for example, for stabilizing the movementof teeth prior to, subsequent to or concurrently with orthodontictreatment. Accordingly in other embodiments the present methods furthercomprise performing orthodontic treatment, such as installing one ormore orthodontic appliances to the patient, prior to, subsequent to orconcurrently with the administration of light. In one embodiment theappliance is a retainer device or a passive orthodontic appliance. Forexample, suitable appliances include removable retainers such as aHawley retainer or a vacuum formed retainer, or fixed retainers such asa bonded lingual retainer. These appliances can assist in maintainingtooth position prior to, subsequent to or concurrently with theadministration of light, for example by stimulating bone regeneration.Administration with light having a wavelength in the range of about 815nm to about 895 nm, or about 835 nm to about 875 nm, or about 845 nm toabout 865 nm, or about 855 nm, can also be useful for stabilizing toothmovement, in one embodiment prior to, subsequent to or concurrently withorthodontic treatment. In one embodiment administration of light havingwavelengths in the range of about 585 nm to about 665 nm increases boneregeneration to a greater degree or extent that does administration oflight having wavelengths in the range of about 815 nm to about 895 nm.

Tooth-root resorption can include breakdown or destruction, orsubsequent loss, of the root structure of a tooth. Tooth-root resorptioncan be caused by differentiation of macrophages into osteoclasts insurrounding tissue which, if in close proximity to the root surface canresorb the root surface cementum and underlying root dentine. The causeof the tooth-root resorption can be increased supra physiologic pressureon the periodontium which can cause cell death of bone soft tissue andbone in the periodontium. This can create an area of hyalinized tissuewhich then stimulates the macrophages and multi-nuclear giant cells toresorb the necrotic tissue and in the process can cause cementum anddentin resorption of the root.

Accordingly, administering light having a particular wavelength, isuseful for modulating the speed, quality and type of tooth movement,e.g., bodily versus tipped, and for increasing or stabilizing toothmovement. In some embodiments, stabilizing tooth movement can comprisemoving one or more teeth with less tipping. Stabilizing tooth movementcan also include retarding or arresting tooth movements in particularways. For example, this can include minimizing the amount of, oreliminating, slanting. Administration of light can also be useful forincreasing bone regeneration. Administration of light can also be usefulfor reducing, minimizing, or preventing tooth root resorption, boneresorption, inflammatory dentin or cementum resorption, or inflammationof tissue.

In some embodiments, the light can be administered to substantially theentirety of a patient's maxillary and mandibular bone. Alternatively,using a light-therapy apparatus or other suitable apparatus, light ofone or more particular wavelengths can be administered to differentselected regions of a patient's maxillary and mandibular alveolar bonein order to effect movement of teeth (e.g. anchor (no movement), bodily,or tipped) in one or more regions of a patient's mouth. For example, oneor more regions in which it is desired that the teeth not be moved, orthat the teeth serve as an anchor to facilitate movement of teeth inother selected regions of a patient's jaw, can be optionally screened ormasked such that they receive no light. Regions in which it is desiredthat the teeth be moved bodily can be administered with light having awavelength in the range of about 585 nm to about 665 nm, in the range ofabout 605 nm to about 645 nm, about 615 nm to about 635 nm, or about 625nm. Regions in which it is desired to increase tooth movement but permitsome tipping of the teeth can be administered with light having awavelength in the range of about 815 nm to about 895 nm, about 835 nm toabout 875 nm, about 845 nm to about 865 nm, or about 855 nm. Toothmovement can be selectively regulated by administering an effectiveamount of light having one wavelength to one or more selected regions ofa patient's maxillary or mandibular alveolar bone, and by administeringan effective amount of light having a different wavelength to one ormore different selected regions of the bone.

In some embodiments, light can be administered within a narrow range ofwavelengths (e.g., 50 nm or less, 30 nm or less, 20 nm or less, 10 nm orless, 5 nm or less), or at a single wavelength. In some embodiments,light can be emitted at one, two, or more peak wavelengths of emission.A peak wavelength is the wavelength at which the highest intensity oflight is emitted. In some embodiments, light can be administered at arange of wavelengths that includes a peak wavelength having the highestintensity within the range. In some embodiments, a peak wavelength canbe at about 620 nm, about 640 nm, about 650 nm, about 655 nm, about 660nm, about 665 nm, about 670 nm, about 680 nm, about 690 nm, about 800nm, about 820 nm, about 830 nm, about 835 nm, about 840 nm, about 845nm, about 850 nm, about 860 nm, about 870 nm, or about 890 nm.

Where two or more light wavelengths are administered, the light can beadministered at any ratio of each wavelength's intensity. For example,light administered at a first wavelength can have an intensity that isabout 1.1×, 1.2×, 1.3×, 1.5×, 1.7×, 2.0×, 2.5×, 3.0×, 3.5×, 4.0×, 5.0×,10×, 12×, 15×, 20×, 30×, 50×, 100× that of light administered at asecond wavelength. In some embodiments, the administered light isemitted from one or more light emitters, in another embodiment, from oneor more light emitters having a first set of properties and, optionally,from a second set of light emitters having a second set of properties.In other embodiments, the number of light emitters having a first set ofcharacteristics exceeds that of the light emitters having a second setof characteristics. For example, the number of light emitters having thefirst set of characteristics can be about 1.1×, 1.2×, 1.3×, 1.5×, 1.7×,2.0×, 2.5×, 3.0×, 3.5×, 4.0×, 5.0×, 10×, 12×, 15×, 20×, 30×, 50×, 100×the number of light emitters having the second set of characteristics,or vice versa.

The light can optionally be substantially monochrome. Administeringlight from light emitters that emit at multiple wavelengths can allowfor irradiation over multiple wavelengths or greater selectivity andprecision in administration. The light can optionally compriseincoherent light. In some embodiments, light can be administered at asingle frequency, light can have a phase that drifts relatively quickly,a pulse of light waves can have an amplitude that changes quickly, or alight wave can encompass a broad range of frequencies.

Light can be administered directly from a light emitter. Light can beemitted and can travel directly through a patient's face to a region. Inanother embodiment, the light is administered nontransdermally to aregion or the oral tissue above the region. In some embodiments, lightcan be modified by optics before reaching the patient's face ortraveling through the patient's face. For example, light can bediffused, focused, parallel, reflected, redirected, or filtered after itis emitted and before it reaches the patient's face or travels throughthe patient's face. In one embodiment, light of one or more wavelengthscan be selectively blocked or partially filtered before reaching thepatient's face or a region. In some embodiments, light can diverge orconverge from an emission source before reaching the region. Forexample, light can diverge in a beam having an included angle θ in therange of about 45-60°. The emitted light diverge to have an includedangle θ of 0 to about 15°, 0 to about 30°, 0 to about 45°, 0 to about60°, 0 to about 75°, 0 to about 90°, or 0 to about 120°.

Light that irradiates the region can optionally have the same or aboutthe same characteristics as light that is emitted. In some embodiments,light that reaches the region does not have the same characteristics asthe light that is emitted. One or more of the light characteristics canoptionally be altered prior to administration or when it passes throughthe face of the patient. One or more of the light characteristics canoptionally be altered when it passes through optics, such as one or morelenses or mirrors. For example, one or more of the light characteristicscan be altered in the range of about ±20% or less, about ±15% or less,about ±10% or less, about ±5% or less, about ±3% or less, about ±1% orless, about ±0.5% or less, or about ±0.1% or less.

An effective amount of light can range from about 24 J/cm² to about 200J/cm². The effective dosage of light can be administered once orrepetitively. In some embodiments, the effective amount of light canhave a light energy density that is from about 30 J/cm² to about 100J/cm². In other embodiments, the effective amount of light can be about5 J/cm² or less, about 10 J/cm² or less, about 20 J/cm² or less, about30 J/cm² or less, about 50 J/cm² or less, about 75 J/cm² or less, about100 J/cm² or less, about 125 J/cm² or less, about 150 J/cm² or less,about 175 J/cm² or less, or about 200 J/cm² or less. The effectiveamount of light can be about 1 J/cm² or more, about 5 J/cm² or more,about 10 J/cm² or more, about 20 J/cm² or more, about 25 J/cm² or more,about 30 J/cm² or more, about 40 J/cm² or more, about 50 J/cm² or more,about 60 J/cm² or more, about 75 J/cm² or more, about 100 J/cm² or less,about 125 J/cm² or more, about 150 J/cm² or more, or about 175 J/cm² ormore. The effective amount of light can be in a range bounded by any ofthe energy density values described above. The effective amount of lightcan be increased, for example, by using a light source that emits lighthaving a relatively higher average intensity, or by increasing theduration of administration of light.

The duration over which the effective amount, which is optionallyrepetitive, is administered can range from about 10 to about 40 minutes.In other embodiments, dosage can be administered in a period of time ofabout 30 seconds or more, about 1 minute or more, about 2 minutes ormore, about 3 minutes or more, about 5 minutes or more, about 7 minutesor more, about 10 minutes or more, about 15 minutes or more, about 20minutes or more, about 25 minutes or more, about 30 minutes or more,about 40 minutes or more, about 50 minutes or more, about 1 hour ormore, about 1 hour 15 minutes or more, about 1 hour 30 minutes or more,or about 2 hours or more. The effective amount can be administered in aperiod of time of about 3 minutes or less, about 5 minutes or less,about 10 minutes or less, about 15 minutes or less, about 20 minutes orless, about 25 minutes or less, about 30 minutes or less, about 35minutes or less, about 40 minutes or less, about 50 minutes or less,about 1 hour or less, about 1 hour 15 minutes or less, about 1 hour 30minutes or less, about 2 hours or less, or about 4 hours or less. Theeffective amount can be administered in a range of time within any ofthe time values mentioned above. Such light therapy can include lightemission that has been provided extra-orally. In some embodiments, oneor more intra-oral light blocking masks or shades can be used. An oralmask can block one or more wavelengths of light, or can reduce theintensity of one or more wavelengths of light, from reaching a regioncovered by the oral mask. This can include an upper arch (e.g.,maxillary teeth), or lower arch (e.g., mandibulary teeth). Accordinglyin other embodiments the methods further comprise applying an intra-oralor extra-oral shade or mask to the patient. The intra-oral or extra-oralshade or mask can be applied prior to or concurrently with theadministration of light.

Any time period can be provided between dosages of effective amounts oflight. For example, the time period between dosages can be on the orderof seconds, minutes, hours, days, weeks, months, quarter of a year, oryears.

The effective amount, which in some embodiments is repetitive, can beadministered with any desired frequency, e.g., four times daily, threetimes daily, twice daily, daily, every second day, weekly, biweekly,monthly, or quarterly. In some embodiments, dosage can be administeredat regular intervals (e.g., daily), while in other embodiments, thedosage is not administered at regular intervals (e.g., administrationcan occur 2 times a week at any time during the week). In oneembodiment, light can be administered in the morning and at night. Lightcan be administered throughout the time period that a patient isundergoing orthodontic treatment, or following treatment to stabilizetooth movement. For example, light can be administered after anappliance is applied, removed, adjusted, after an appointment, or afteran active phase, as described herein. It can be desirable to administerlight with greater frequency, e.g. four times daily, three times daily,twice daily, daily or every second day, while a patient is undergoingorthodontic treatment. Where light is being administered, for example,to stabilize tooth movement or reduce tooth-root resorption, treatmentsof reduced frequency, e.g. weekly, biweekly, monthly, or quarterly, canbe used to minimize inconvenience to patients. In some embodiments, theeffective amount of light maintains the ATP energy levels of tissuecells, e.g., ischemic tissue cells, to prevent cell death, as describedabove. In some embodiments, light is administered no less than aboutevery second day. In some embodiments, a patient receives lighttreatment at least three or four times a week.

Light can be administered for any length of time. In some embodiments,light can be administered on the order of weeks, months, quarters, oryears. For example, light can be administered while a heavy force isexerted on one or more teeth. One or more dosages of light can beadministered over a period of time during which a heavy force is exertedon one or more teeth, during which a patient is wearing an orthodonticappliance that itself can exert a heavy force, or during which a patientis undergoing orthodontic treatment during which a heavy force may beapplied. In some embodiments, while a patient is undergoing orthodontictreatment or is wearing an orthodontic appliance, a patient isadministered with light. Administration of light, which may includeregular, irregular, continuous or discontinuous administration of light,can be on the order of days, weeks, months, quarters, or years. In someembodiments, light is administered over a plurality of days, weeks,months, quarters, or years. In some embodiments, light is administeredover a plurality of sessions. In some embodiments, one or more hours,days, weeks, months, quarters, or years occur between sessions.

If the light emitters are pulsed, then their duty cycle can be adjustedas desired; e.g., light can be administered with a duty cycle of about10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%,about 80%, or about 90%. The pulsing can occur with any frequency. Forexample, light can be pulsed every picosecond, nanosecond, microsecond,millisecond, second, multiple seconds, or minutes. Frequencies caninclude, but are not limited to, about 1 mHz, about 10 mHz, about 50mHz, about 100 mHz, about 500 mHz, about 1 Hz, about 2 Hz, about 5 Hz,about 10 Hz, about 15 Hz, about 20 Hz, about 25 Hz, about 30 Hz, about35 Hz, about 40 Hz, about 50 Hz, about 70 Hz, about 100 Hz, about 200Hz, about 500 Hz, or about 1 kHz. Any of the aforementionedcharacteristics of light emission (e.g., whether the light is on or off,continuous or pulsed, duty cycle, frequency, intensity, wavelength) canbe varied or maintained. Where the light is emitted from a source havinga controller, any characteristics of light emission can be varied ormaintained in accordance with instructions from its controller.

Where the light is emitted from one or more lights, light can becontrolled so that the number of lights that are on or off at a givenperiod can be individually controllable. For example, a light source canbe turned on or off relative to other light sources. Various lightsources can be modulated individually, to expose individual sections ofa patient's maxillary and mandibular alveolar bone or other regions to adesired energy density. This can be desirable when it is desirable toadminister light to different regions. Thus, the position of light beingadministered can be varied. In another embodiment, different types oflight sources can be turned on or off relative to other light emitters.For example, at some times, light emitted in a first wavelength rangecan be turned on while light emitted in a second wavelength range can beturned off, vice versa, or both types of light emitters can be turned onor off. Thus, the wavelength of light being administered can be varied.In some embodiments, the intensity of light being administered can bevaried (e.g., by turning some light sources on or off, or varying theintensity emitted by the light sources). Administering light selectivelycan enable an increased anchorage effect (by reason of lower toothmobility) of teeth which are not exposed to any light, which can therebypermit for more precise movement of teeth to which light isadministered.

In some embodiments, particularly where infrared light is administeredto a patient, the present methods further comprise providing emission ofa visible light c. In one embodiment the visible light is bright, e.g.,uncomfortable for a patient to look at. The bright visible light candeter users or patients from looking into a light source when it isoperating, can provide a perceptible indication that a light is beingemitted, and can be useful in properly positioning a light source. Thevisible light can be, but is not necessarily, of a wavelength range thatis beneficial for light therapy or regulation of tooth movement. In someembodiments, the ratio of the intensities of the visible and infraredcomponents of the light is 1 part or less visible light to 5 parts ormore infrared light. In some embodiments, light can be emitted within arange can include wavelengths less than an order of magnitude relativeto one another. Alternatively, the range can include wavelengths emittedat one, two, three or more orders of magnitude relative to one another.

The region and desired light characteristics can vary from patient topatient. A physician, dentist or patient can determine a light treatmentregimen for a patient. In some embodiments, he or she can use alight-therapy apparatus that administers light to provide the desiredtreatment.

In some instances, it can be desirable to administer light to less thanall regions of the patient's maxillary or mandibular alveolar bone, forexample, if it is desired that teeth in other regions do not need to bemoved (e.g. it can be desired to regulate the movement of only the upperteeth of a patient, or only the lower teeth, or to use certain teeth asan anchor when regulating the movement of other teeth by administeringno light to, e.g., blocking light from, the anchor teeth). Administeringlight to selected regions of the patient's maxillary or mandibularalveolar bone can comprise causing light to irradiate one or moreselected tooth roots through the bone.

In one embodiment, light is selectively administered to less than allregions of the patient's mouth before, during, or after the exertion ofheavy forces. In one embodiment, light is not administered to an anchortooth. In this embodiment, an orthodontic appliance can be locatedbetween the anchor tooth and one or more other tooth. The orthodonticappliance can exert a force on another tooth. In some embodiments, theforce is a heavy force. In some embodiments, an effective amount oflight is administered to the other tooth and not to the anchored tooth.The administration of light can increase the velocity of the other toothand reduce, minimize, or prevent root resorption of the other tooth,while not increasing the velocity of the anchor tooth.

It can also be desirable to administer light of different wavelengths todifferent regions of the patient's maxillary or mandibular alveolarbone, if it is desired to differentially manipulate the movement of apatient's teeth, as described below. For example, light of a firstwavelength can be administered to a first region and light of a secondwavelength can be administered to a second region. The first and secondwavelengths can include any wavelengths described elsewhere herein, suchas about 585 nm to about 665 nm, or about 815 nm to about 895 nm.

Light can be administered over an area. For example, light can beadministered to a region with an area. In some embodiments, lightcharacteristics can remain uniform over the area. In other embodiments,light characteristics can vary over the area. For example, lightintensity can be uniform or can vary over an area of a region. The areaof light administration can have any shape or size.

Light can be administered to a light irradiation area of any size andshape. For example, a region, such as a specified region of thepatient's maxillary or mandibular alveolar bone, can have any size orshape. One or more dimensions of a light irradiation area can range fromabout 1 to about 80 mm, in another embodiment from about 1 to about 70mm. In some embodiments, one or more dimensions (e.g., length, width,diameter) of a light irradiation area can range from about 1 to about 3mm, about 3 to about 5 mm, about 5 to about 7 mm, about 7 to about 10mm, about 10 to about 15 mm, about 15 to about 20 mm, about 20 to about25 mm, about 25 to about 30 mm, about 30 to about 35 mm, about 35 toabout 40 mm, about 40 to about 50 mm, about 50 to about 60 mm, or about60 to about 80 mm.

A light-irradiation area can have any shape, which can include, but isnot limited to, a substantially rectangular shape, square shape,triangular shape, hexagonal shape, octagonal shape, trapezoidal shape,circular shape, elliptical shape, crescent shape, cylindrical shape orhalf-circle. In some embodiments, the dimensions of a light source canbe about the same as dimensions for a light irradiation area. In otherembodiments, the dimensions of a light source can be greater than thedimensions of a light irradiation area. Alternatively, the dimensions ofa light source can be less than the dimensions of the light irradiationarea. The relative areas of a light source and light irradiation areacan depend on any angle, which can be a parallel, convergence, ordivergence angle, at which light is emitted.

In some embodiments, an effective amount of light can be provided in atreatment regimen. The treatment regimen can be used in the presentmethods.

In one embodiment, a typical treatment regimen provides a dose of lightdaily. Each of the daily doses of light can be administered over aperiod lasting from a few minutes to about an hour. For example, daily ½hour doses of light can be effective and are not unduly inconvenient forpatients. A single daily dose can be as effective as dividing the samedose into multiple sessions administered at different times during theday. Some treatment regimens can comprise administering light in 5treatments per week for 12 weeks. Each treatment can last ½ hour andirradiate the tissues of a patient's jaw with light having wavelengthsof 660 nm and 840 nm. The 660 nm light can have an intensity of about 20mW/cm² at the skin's surface. The 840 nm light can have an intensity ofabout 10 mW/cm² at the skin's surface. These treatment regimens canenhance bone density.

Other treatment regimens can comprise administering light in dailytreatments for 21 days. Each treatment lasts between 20 minutes and onehour and illuminates the tissues of a patient's jaw with light having awavelength of 618 nm and an intensity of 20 mW/cm² at the skin'ssurface. These treatment regimens can accelerate healing of bone grafts.

Another treatment regimen can include a twice-daily administration oflight for six months. In one embodiment the light is administered from alight-therapy apparatus. Light can be administered at a wavelength ofabout 660 nm or about 840 nm, or at both wavelengths. The intensity ofthe light can be about 20 mW/cm² at the skin's surface. An orthodonticappliance can be present in the patient's mouth while the light isadministered. Subsequent to the first 6 month period, a second 6 monthperiod can be provided where light is administered once every other day.The same orthodontic appliance or one or more different orthodonticappliances can be present in the patient's mouth at this time. Theadministration of light can optionally become less frequent or beadministered at a lower intensity as treatment progresses.

Another treatment regimen can include administering light to a toothhaving an orthodontic appliance and subsequently adjusting theorthodontic appliance. In some embodiments, adjusting an orthodonticappliance may increase or alter the magnitude of a force applied on oneor more teeth. Adjusting an orthodontic appliance may alter thedirection of a force applied on one or more teeth. Light can beadministered to one or more selected teeth for up to an hour prior toadjusting an orthodontic appliance. Adjusting the orthodontic appliancecan cause a heavy force to be exerted on the one or more teeth.Adjusting the appliance can change the magnitude or direction, or both,of the force exerted. Adjusting the appliance can comprise tightening,loosening or replacing one or more of the appliance's wires, springs orelastic devices. Different sizes, materials, or shapes of suchcomponents can be used. Light can then be applied daily to the one ormore selected teeth, until the next adjustment of the appliance. Thisadministration of light can reduce, minimize, or prevent tooth-rootresorption, bone resorption, tissue inflammation, periodontiumresorption or cementum resorption.

The present methods can further comprise controlling temperature of thepatient's face or of any light source that is directed at or thatcontacts a patient's face or a region. For example, the method caninclude cooling, heating, or maintaining the temperature at a patient'sface. A patient's face can be contacted with a temperature controlmechanism, which can cause the removal or provision of heat. In someembodiments, heat can be generated by the light source. In someembodiments, the temperature of the light source can be controlled. Atemperature control mechanism can communicate with the light source.Heat can be removed from or provided to the light source. Anyembodiments for temperature regulation described herein can be usedwithin the method. The method can further comprise measuring atemperature at a patient's face or at a light source. Temperatureregulation can optionally occur in response to one or more temperaturemeasurements made.

In one embodiment the present methods are performed prior to, subsequentto or concurrently with orthodontic treatment of a patient. In oneembodiment the administration of light is repetitive.

An orthodontic treatment can cause one or more teeth to move or maintainits position relative to a supporting maxilla or mandible, or caninclude regulation of tooth movement. In some instances, orthodontictreatment can include aligning teeth. Orthodontic treatment can includetreating malocclusion, which can occur when teeth fit togetherimproperly, for example, as a result of their individual positions orpositions of underlying jaw bone as they relate to one another.Malocclusion can be treated using light therapy or tooth movementregulation according to the methods described herein. Accordingly, thepresent invention further relates to methods for treating or preventingmalocclusion, comprising allowing a heavy force to be exerted on one ormore teeth of a patient in need thereof and extra-orally administeringan effective amount of light to the maxillary or mandibular alveolarbone of the patient, where the light is administered before, during orafter the heavy force is exerted. In another embodiment, methods fortreating or preventing malocclusion comprise allowing a heavy force tobe exerted on one or more teeth of a patient in need thereof andintra-orally administering an effective amount of light to the maxillaryor mandibular alveolar bone of the patient, where the light isadministered before, during or after the heavy force is exerted.

An orthodontic treatment can include the application of an orthodonticappliance to a patient. An orthodontic appliance can be present on oneor more teeth of a patient. The methods can comprise installing anorthodontic appliance to a patient, such as installing the appliance toone or more teeth of the patient, adjusting an orthodontic appliance ofthe patient, or can comprise removing an orthodontic from the patient.Orthodontic treatment can include a period of time during which theorthodontic appliance is applied to the patient. In some embodiments,orthodontic treatment can include a period of time after the orthodonticappliance has been applied or removed from the patient. In someembodiments, orthodontic treatment can include a period of timepreceding the application of an orthodontic appliance. In otherembodiments orthodontic treatment includes a period of time prior to,during, or subsequent to the exertion of a heavy force on one or moreteeth. Orthodontic treatment can include a period of time while apatient is seeing or consulting with an orthodontist.

In some embodiments, orthodontic treatment can include an active stageand a passive stage. An active stage can include some time during whichan orthodontic appliance is applied to the patient. In some instances,an active stage can include a time during which a force is applied to atooth to effect tooth movement. In some examples, the force applied to atooth during an active stage is a heavy force. An active stage caninclude a period during which the patient is undergoing one or moreadjustments to the patient's appliance. A passive stage can include aperiod after an appliance has been removed from the patient. In someinstances, a passive stage can include a period during which anappliance is applied but is no longer undergoing adjustments. In someinstances a passive stage can include a period during which an applianceis not providing force to effect movement of a tooth. Instead, thepassive stage can include a period during which an appliance is appliedto a patient and that maintains one or more teeth in its position. Insome embodiments, any stage of orthodontic treatment can last on theorder of days, weeks, months, quarters, or years.

In some embodiments, orthodontic treatment can result in boneremodeling. Force can be exerted on one or more tooth, any region of thejaw, or any other region of the mouth or head. Force can be exerted byan orthodontic appliance. In some embodiments, the force is a heavyforce. Bone remodeling can involve altering the position or morphologyof bone, including the jaw bone. For example, a jaw bone can be movedforward, or can be lengthened. In some embodiments, bone remodeling canoccur in conjunction with regulating tooth movement. Accordingly, thepresent methods are useful for and in one embodiment result in boneremodeling. Light can be administered to a region, such as a region of ajawbone, or any oral bone or tissue, and is useful for bone remodeling.Accordingly, the invention further provides methods for inducing boneremodeling, comprising allowing a heavy force to be exerted on one ormore teeth of a patient in need thereof and extra-orally or intra-orallyadministering an effective amount of light to the maxillary ormandibular alveolar bone of the patient, where the light is administeredbefore, during or after the heavy force is exerted. Light therapy can beprovided in conjunction with bone remodeling, and can increase the rateof bone remodeling. For example, applying an effective amount of lightas described in the present methods can reduce the amount of time toachieve the same degree of bone remodeling without light by about 10%,about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about80%, or about 90%. Light treatment can promote bone remodeling which canincrease the rate of teeth movement. This can allow heavier forces to beused, which could accelerate tooth movement even more than with lighterforces. Such forces can be exerted by one or more appliances.

The present methods can be performed on a patient prior to being appliedwith one or more orthodontic appliances, during a time when the patientwears one or more orthodontic appliances, or after one or moreorthodontic appliances has been removed from the patient. An orthodonticappliance can be fixed or movable with respect to a patient's teeth.Orthodontic appliances can include, for example, fixed active appliancessuch as pin and tube appliances, appliances using wires or brackets orsprings, ribbon arch appliances, Begg lightwire appliances, edgewiseappliances, pre-adjusted edgewise appliances, self-ligating edgewiseappliances, bi-helix, tri-helix, quad-helix, rapid maxillary expansionappliance (RPE); removable active appliances such as expansion andlabial segment alignment appliance INVISALIGN™; functional appliancessuch as herbst, bionator, frankel, biobloc, activator; orthodonticheadgear including reverse headgear and conventional headgear; and othertypes of orthodontic apparatus. Orthodontic appliances are commerciallyavailable and can include specifications (or other documentation) thatspecify the magnitude of force that the appliance is capable of exertingon one or more teeth. In some embodiments, the orthodontic appliancecomprises steel wires, nickel titanium wires, or titanium molybdenumwires. In some embodiments, the orthodontic appliance comprises wires orsprings that are of a high gauge. Some examples of wires that anorthodontic appliance can comprise are stainless steel ornickel-titanium wires having wire dimensions of:

0.0160″ square 0.406 mm square 0.0160″ × 0.0220″ 0.406 mm × 0.559 mm0.0170″ square 0.432 mm square 0.0170″ × 0.0220″b 0.432 mm × 0.559 mm0.0170″ × 0.0250″ 0.432 mm × 0.635 mm 0.0180″ square 0.457 mm square0.0180″ × 0.0220″ 0.457 mm × 0.559 mm 0.0180″ × 0.0250″ 0.457 mm × 0.635mm 0.0190″ square 0.483 mm square 0.0190″ × 0.0250″ 0.483 mm × 0.635 mm0.0200″ square 0.508 mm square 0.0210″ × 0.0250″ 0.533 mm × 0.635 mm

Nickel-titanium closed or open-coil springs can be used. Some examplescan include an elastomeric power chain, which can be capable ofproviding 100-800 grams of force, or intra-arch elastics. In someembodiments, the orthodontic appliance comprises an elastic material. Anorthodontic appliance can exert a force on one or more teeth of thepatient. In some embodiments, the orthodontic appliance can exert or beconfigured to exert a heavy force on one or more teeth of the patient.The orthodontic appliance can cause one or more teeth to move ormaintain its position.

A heavy force can be measured using a dynamometer or any similar device.For example, a dynamometer can measure the force that a wire, spring orsimilar mechanism from an orthodontic appliance exerts on one or moreteeth. The measured force can depend on any number of parameters suchas, for example, the gauge of the wire or the stiffness of the wire. Inthis manner, in some embodiments, a heavy force can be calculated, inpart, by measuring the tension or stiffness of the appliance's wire (orspring or similar mechanism), e.g., when such force is exerted on one ormore teeth. Furthermore, in some embodiments, the appliance's wire (orspring or similar mechanism) is constructed from a material that issensitive to temperature such that the stiffness of the wire, andtherefore the heavy force exerted by that wire, can change based on thetemperature of the wire. For example, in some embodiments, the stiffnessof the wire (or spring or similar mechanism) increases when the wiretemperature increases, and decreases when the wire temperaturedecreases. Thus, in some such embodiments, a heavy force can becalculated, in part, by measuring the temperature of the wire (or springor similar mechanism) or estimating its temperature when present in apatient's oral cavity. With respect to the gauge of the wire, it isgenerally well known in the art that increasing the gauge (orcross-section) of a wire can increase the stiffness of the wire whichultimately increases the heavy force that the wire exerts on one or moreteeth.

Installing, adjusting, or removing of an orthodontic appliance can occurbefore or after administering an effective dosage of light. In someembodiments, the effective amount of light can aid in regulating oraccelerating the movement of teeth during orthodontic treatment with anorthodontic appliance. The effective amount of light can be useful forreducing the amount of time an orthodontic appliance is worn during anorthodontic treatment. For example, according to the methods of thepresent invention, the application of light can reduce treatment time(e.g., wearing orthodontic devices) by up to about 10%, about 20%, about30%, about 40%, about 50%, about 60%, about 70%, about 75%, about 80%,about 85%, or about 90% of the treatment time. For example,administering light having a wavelength in the range of about 585 nm toabout 665 nm (e.g., about 625 nm) can reduce the amount of time that apatient wears orthodontic appliances by about 5% to about 90%, forexample, by about 5%, about 10%, about 20%, about 30%, about 40%, about50%, about 60%, about 70%, about 75%, about 80%, about 85%, or about90%. Administering light having a wavelength in the range of about 815nm to about 895 nm (e.g., about 855 nm) can reduce the amount of timethat a patient wears orthodontic appliances by about 5% to about 90%,for example, by about 5%, about 10%, about 20%, about 30%, about 40%,about 50%, about 60%, about 70%, about 75%, about 80%, about 85%, orabout 90%.

Administering light having a wavelength in the range of about 585 nm toabout 665 nm (e.g., about 625 nm) can result in a rate of tooth movementthat is about 5% to about 90% faster than the rate of tooth movementwithout the administration of light. For example, the rate of toothmovement can be about 5%, about 10%, about 20%, about 30%, about 40%,about 50%, about 60%, about 70%, about 75%, about 80%, about 85%, orabout 90%.

Administering light having a wavelength in the range of about 815 nm toabout 895 nm (e.g., about 855 nm) can result in a rate of tooth movementthat is about 5% to about 60% faster than the rate of tooth movementresulting from the administration of light having a wavelength in therange of 585 nm to about 665 nm (e.g., about 625 nm). For example, therate of tooth movement can be about 5%, about 10%, about 20%, about 30%,about 40%, about 50%, about 55%, or about 60%.

Administering light having a wavelength in the range of about 815 nm toabout 895 nm (e.g., about 855 nm) can result in a rate of tooth movementthat is about 5% to about 95% faster than the rate of tooth movementwithout the administration of light. For example, the rate of toothmovement can be about 5%, about 10%, about 20%, about 30%, about 40%,about 50%, about 60%, about 70%, about 75%, about 80%, about 85%, about90%, or about 95%.

Orthodontic treatments, particularly those that comprise the use of anorthodontic appliance, can exert heavy forces on one or more teeth. Thiscan result in a rate of tooth movement that is about 5% to about 80%faster than the rate of tooth movement without the exertion of heavyforces. For example, the exertion of heavy forces in one or more teethcan increase the rate of tooth movement by about 5%, about 10%, about20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 75%,or about 80%.

In some embodiments, the administration of an effective amount of lightcan aid in reducing, preventing or minimizing tooth-root resorption whena heavy force is allowed to be exerted on one or more tooth. Theeffective amount of light can be useful for reducing the amount oftooth-root resorption as compared to when a heavy force is allowed to beexerted on one or more tooth without administering the effective amountof light. For example, according to the methods of the presentinvention, the administration of light can reduce tooth-root resorptionby up to about 1%, about 2%, about 3%, about 5%, about 7%, about 10%,about 15%, about 20%, about 25%, about 30%, about 40%, about 50%, about60%, about 70%, about 80%, or about 90%. Reducing tooth-root resorption,particularly while applying heavy forces, may allow for a reduction ofthe amount of time for orthodontic treatment, or the amount of time thata patient wears an orthodontic appliance. Administering an effectiveamount of light can reduce the amount of time that a patient wearsorthodontic appliances by about 5% to about 90%, for example, by about5%, about 10%, about 20%, about 30%, about 40%, about 50%, about 60%,about 70%, about 75%, about 80%, about 85%, or about 90%.

In some embodiments, administration of an effective amount of light canaid in reducing, preventing or minimizing bone resorption orinflammatory dentin or cementum resorption of the tooth root orperiodontium. The effective amount of light can be useful for reducingbone resorption or inflammatory dentin or cementum resorption of thetooth root and periodontium, as compared to when a heavy force isallowed to be exerted on one or more teeth without administering theeffective amount of light. For example, according to the methods of thepresent invention, the administration of light can reduce boneresorption or inflammatory dentin or cementum resorption of the toothroot or periodontium by up to about 1%, about 2%, about 3%, about 5%,about 7%, about 10%, about 15%, about 20%, about 25%, about 30%, about40%, about 50%, about 60%, about 70%, about 80%, or about 90%. Reducingbone resorption or inflammatory resorption of dentin or cementumresorption of the tooth root or periodontium while exerting heavy forcescan reduce the amount of time for orthodontic treatment, or amount oftime that a patient wears an orthodontic appliance. Administering aneffective amount of light can reduce the amount of time that a patientwears orthodontic appliances by about 5% to about 90%, for example, byabout 5%, about 10%, about 20%, about 30%, about 40%, about 50%, about60%, about 70%, about 75%, about 80%, about 85%, or about 90%.

In some embodiments, administration of the effective amount of light canaid in reducing, preventing or minimizing inflammation of tissuesurrounding one or more teeth upon which heavy forces are or wereexerted. The effective amount of light can be useful for reducing theamount of inflammation of tissue surrounding one or more teeth uponwhich heavy forces are or were exerted, as compared to when a heavyforce is allowed to be exerted on one or more tooth withoutadministering the effective amount of light. In one embodiment,according to the methods of the present invention, the administration oflight can reduce inflammation of tissue surrounding one or more teethupon which heavy forces are or were exerted by up to about 1%, about 2%,about 3%, about 5%, about 7%, about 10%, about 15%, about 20%, about25%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%,or about 90%. Reducing inflammation of tissue surrounding one or moreteeth upon which heavy forces are or were exerted while applying heavyforces can reduce the amount of time for orthodontic treatment, oramount of time that a patient wears an orthodontic appliance.Administering an effective amount of light can reduce the amount of timethat a patient wears an orthodontic appliance by about 5% to about 90%,for example, by about 5%, about 10%, about 20%, about 30%, about 40%,about 50%, about 60%, about 70%, about 75%, about 80%, about 85%, orabout 90%.

The light can be administered in accordance with a treatment regimen. Insome embodiments, an orthodontic appliance can be installed prior toextra-orally or intra-orally administering the light, an orthodonticappliance can be installed concurrently with extra-orally orintra-orally administering the light, an orthodontic appliance can beinstalled subsequent to extra-orally or intra-orally administering thelight, or any combination thereof. In some embodiments, an orthodonticappliance can be removed prior to extra-orally or intra-orallyadministering the light, an orthodontic appliance can be removedconcurrently with extra-orally or intra-orally administering the light,an orthodontic appliance can be removed subsequent to extra-orally orintra-orally administering the light, or any combination thereof. Insome embodiments, an orthodontic appliance can be adjusted prior toextra-orally or intra-orally administering the light, an orthodonticappliance can be adjusted concurrently with extra-orally or intra-orallyadministering the light, an orthodontic appliance can be adjustedsubsequent to extra-orally or intra-orally administering the light, orany combination thereof.

The orthodontic appliance can exert a heavy force on one or more teethof the patient. A heavy force can be exerted subsequent to, concurrentlywith, or prior to the administration of light. A heavy force may beexerted subsequent to, concurrently with, or prior to initiation of theadministration of light. A heavy force can be exerted subsequent to,concurrently with, or prior to the initiation of a light treatmentregimen. A heavy force can be exerted subsequent to, concurrently with,or prior to the initiation of a light treatment session. In someembodiments, a heavy force can be exerted one or more seconds, one ormore minutes, one or more hours, one or more days or one or more weekssubsequent to administering the light and/or one or fewer days, one orfewer weeks, or one or fewer weeks subsequent to administering thelight. The light can be administered for any length of time. In someembodiments, a heavy force is exerted one or more seconds, one or moreminutes, one or more hours, one or more days or one or more weekssubsequent to initiating light administration and/or one or fewer days,one or fewer weeks, or one or fewer weeks subsequent to initiating lightadministration. In some embodiments, a heavy force can be exerted one ormore seconds, one or more minutes, one or more hours, one or more daysor one or more weeks subsequent to ending light administration and/orone or fewer days, one or fewer weeks, or one or fewer weeks subsequentto ending light administration.

Light can be administered for any period of time before, during, orafter the exertion of a heavy force. For example, light can beadministered for about 1 minute, about 2 minutes, about 3 minutes, about5 minutes, about 10 minutes, about 15 minutes, about 20 minutes, about30 minutes, about 45 minutes, about 1 hour, about 90 minutes, about 2hours, about 3 hours, about 4 hours, or about 6 hours prior to, during,or after the exertion of a heavy force. In some embodiments, light isadministered at any amount of time prior to, during, or after theinitiation of the exertion of a heavy force. For example, light can beadministered about 1 minute, about 2 minutes, about 3 minutes, about 5minutes, about 10 minutes, about 15 minutes, about 20 minutes, about 30minutes, about 45 minutes, about 1 hour, about 90 minutes, about 2hours, about 3 hours, about 4 hours, about 6 hours, about 12 hours,about 1 day, about 36 hours, about 2 days, about 3 days, about 4 days,about 1 week, about 2 weeks, or about 1 month prior to, during, or afterthe initiation of the exertion of a heavy force.

Thus, a pretreatment of light may be effected prior to the exertion ofthe heavy force. In some embodiments, a heavy force may be exerted atone or more seconds, one or more minutes, one or more hours, one or moredays or one or more weeks prior to administering the light and/or one orfewer days, one or fewer weeks, or one or fewer weeks prior toadministering the light. Thus, a follow-up treatment of light can beprovided after the exertion of the heavy force. In some embodiments, aheavy force is exerted during the administration of light, or at one ormore stages of the administration of light.

In one embodiment, the effective amount can be in the range of about 24J/cm² to about 200 J/cm², and can have a wavelength in the range ofabout 585 nm to about 665 nm, or about 815 nm to about 895 nm.Administration of light having a wavelength in the range of about 585 nmto about 665 nm is also useful in the present methods, in oneembodiment, for promoting bodily movement of teeth or minimize tippingof teeth, or both.

Administration of light having a wavelength in the range of 815 nm toabout 895 nm, is also useful in the present methods, for example, forincreasing the velocity of teeth through the patient's bone. In someother examples, an effective amount of light can have any of the lightcharacteristics as described anywhere above. Teeth in a region of thepatient's maxillary or mandibular alveolar bone to which light is notadministered can be used as an anchor to facilitate movement of teeth inthe selected region. In one embodiment the light is administered to thepatient's face. In another embodiment, the light can be administereddirectly to a specific region of the patient's maxillary or mandibularalveolar bone.

In some embodiments, the present methods comprise administering to apatient in need thereof an effective dosage of light having a firstwavelength to a selected first region of the patient's maxillary ormandibular alveolar bone, and further comprise administering aneffective dosage of light having a second wavelength to a selectedsecond region of the patient's maxillary or mandibular alveolar bone. Inone embodiment the regulating occurs prior to, subsequent to orconcurrently with orthodontic treatment of a patient. In one embodimentthe effective amount of light having a first wavelength is a repetitivedosage. In another embodiment the effective dosage of light having asecond wavelength is a repetitive dosage. Regions other than alveolarbone can receive the first or second wavelength of light. In oneembodiment, the effective dosage of light can be in the range of 24J/cm² to 200 J/cm². The first wavelength can be in the range of about585 nm to about 665 nm, and the second wavelength can be in the range ofabout 815 nm to about 895 nm. In other examples, an effective amount oflight can have any light characteristics as described anywhere above. Inone embodiment the light is administered to the patient's face.

In some embodiments, the methods further comprise installing anorthodontic appliance, removing an orthodontic appliance or adjusting anorthodontic appliance. In other embodiments, the methods compriseadministering light until orthodontic treatment is complete. Orthodontictreatment can be deemed complete after appointments with an orthodonticspecialist are completed, after the movement of one or more teeth hasbeen stabilized to substantially remain in the same position without theaid of an orthodontic appliance, or during a passive stage oforthodontic treatment as described in greater detail herein. Light canbe administered to the region before, during, after, or any combinationthereof, an orthodontic appliance is installed, adjusted, or removed.The orthodontic appliance can be applied, adjusted, or removed before,during, after, or any combination thereof, the application of light. Insome embodiments, a heavy force can be exerted when the orthodonticappliance is installed or adjusted, or for a period of time followingsuch installation or adjustment.

As described herein, the speed of tooth movement, e.g., through thebone, or the quality of that movement (e.g., “bodily” or “tipping”movement) can be regulated by administration of light. In one embodimentthe present methods are useful for effecting bone regeneration, whichcan occur concurrently with the present methods. Bone regeneration canbe enhanced by administering light according to the present methods. Thelight can be administered before, during or after orthodontic treatment.The light can be emitted from a light-therapy apparatus, such asdescribed herein. Bone regeneration can include bone growth or boneresorption. This can include osteoblast or osteoclast activation. Toothmovement can require osteoclastic and osteoblastic activity. In oneembodiment, the administration of light according to the present methodsstimulates osteoclasts or osteoblasts and, accordingly, stimulatesosteoclastic and osteoblastic activity. The administration of light canenhance bone regeneration that can accompany tooth movement.

For example, the present methods, in one embodiment for regulating toothmovement, can also comprise applying, adjusting or removing a tooth maskor other oral mask. A tooth mask can be applied or removed prior to,during, or after the administration of light. Light can be administeredto a region before, during, after, or any combination thereof, an oralmask or tooth mask is applied, adjusted, or removed. In someembodiments, one or more of a patient's teeth can be at least partiallycovered with a tooth mask that can block at least some of the light. Atooth mask can block one or more wavelengths of light. In someembodiments, the tooth mask can completely block one or more wavelengthof light, and in other embodiments, the tooth mask can reduce the amountor intensity of light reaching the teeth. In some embodiments, theintensity of the light administered to the teeth can be zero, or can beless than the intensity of the light emitted from a light source.

In accordance with another aspect of the invention, the present methods,in one embodiment for tooth-movement regulation, can regulate the boneregeneration. For example, the present methods can increase the rate ofbone regeneration. In some embodiments, bone regeneration can facilitatetooth-movement regulation, for example, can increase the velocity orquality of movement, or can stabilize tooth movement. For example, boneregeneration can occur prior to, during or following tooth movement.Bone regeneration can include bone growth, bone strengthening or boneresorption. For example, during bone regeneration, bone mineral density(BMD) can increase, bone volume (BV) can increase, bone mineral content(BMC) can increase, and the ratio of bone volume to total volume (BV/TV)or bone density can increase. Higher BV/TV can indicate denser bone,where less bone regeneration can occur, which is desirable after toothmovement has occurred to enhance the stability of teeth. Other examplesof parameters that can be affected during bone regeneration can includetrabecular bone surface, bone quality, osteoclastic activity (e.g.,osteoclast and preosteoclast counts), bone resorption. Light therapy canenhance existing cellular processes. Bone regeneration can occur in anybone tissue or oral region. For example, bone regeneration can occur ina portion or all of a maxillary alveolar bone, in mandibular alveolarbone, or around one or more teeth. In some embodiments, boneregeneration can occur around one or more teeth can, which can include aperiodontium. In some embodiments, the region around one or more teethcan be within about 1 mm, about 2 mm, or about 3 mm from the surface ofthe teeth.

In some embodiments, light therapy according to the present methods canalso result in treating or preventing jaw osteonecrosis. Accordingly,the present methods are useful for treating or preventing jawosteonecrosis. Accordingly, the invention further provides methods fortreating or preventing jaw osteonecrosis, comprising allowing a heavyforce to be exerted on one or more teeth of a patient in need thereofand extra-orally or intra-orally administering an effective amount oflight to the maxillary or mandibular alveolar bone of the patient, wherethe light is administered before, during or after the heavy force isexerted. Treating or preventing jaw osteonecrosis can comprise reversingosteonecrosis through the use of light therapy according to the methodsdescribed herein. Jaw osteonecrosis can occur with respect to any bonetissue. For example, jaw osteonecrosis can occur with respect to aportion or all of a maxillary alveolar bone, mandibular alveolar bone,or one or more teeth.

In some embodiments, light therapy according to the present methods canalso result in reducing, minimizing, or preventing tooth-rootresorption, bone resorption, inflammatory resorption of dentin orcementum resorption, or inflammation of tissue. Accordingly, the presentmethods are useful for reducing, minimizing, or preventing tooth-rootresorption, bone resorption, inflammatory dentin or cementum resorption,or inflammation of tissue. Accordingly, the invention further providesmethods for reducing, minimizing, or preventing tooth-root resorption,bone resorption, inflammatory dentin or cementum resorption, orinflammation of tissue, comprising allowing a heavy force to be exertedon one or more teeth of a patient in need thereof; and administering aneffective amount of light to the maxillary or mandibular alveolar boneof the patient, wherein the light is administered before, during, orafter the heavy force is exerted. Such methods may be used or useful inconjunction with heavy forces applied to one or more tooth.

In some embodiments, the region to which light is administered is anyoral tissue, such as soft tissue or bone tissue. In some embodiments,the oral tissue is that on which oral surgery was performed. The presentmethods are useful for treating tissue after oral surgery. The oralsurgery can be periodontal surgery or that relating to bone grafts. Theoral tissue can be: a portion or all of tissue supporting one or moreteeth, the gums, a maxillary alveolar bone, mandibular alveolar bone, orone or more teeth. Accordingly, the invention further provides methodsfor treating tissue after oral surgery, comprising allowing a heavyforce to be exerted on one or more teeth of a patient in need thereofand extra-orally or intra-orally administering an effective amount oflight to a region of the patient's oral tissue on which oral surgery wasperformed, where the light is administered before, during or after theheavy force is exerted. The present methods are also useful forincreasing the rate of oral-tissue healing following oral surgery.Accordingly the invention further provides methods for increasing therate of oral-tissue healing following oral surgery, comprising allowinga heavy force to be exerted on one or more teeth of a patient in needthereof and extra-orally or intra-orally administering an effectiveamount of light to a region of the patient's oral tissue on which oralsurgery will be performed, where the light is administered before,during or after the heavy force is exerted. In some embodiments, themethods further comprise performing oral surgery on the oral tissue. Theoral surgery can be performed prior to or subsequent to theadministration of light therapy according to the present methods. Insome embodiment, the region of light administration can be the alveolarbone. In some embodiments, the light administration occurs extra-orally,and light is transdermally administered to the region. In someembodiments, the light administration can occur intra-orally, and thelight may be directly administered to the region. In some embodiments,the administration occurs for about 20 minutes. In some embodiments, thewavelength of administered light is about 625 nm. In some embodiments,the light may be administered following oral surgery, prior to oralsurgery, or during oral surgery.

In other embodiments, the invention relates to methods for healingdental implants, for example, endosseous dental implants, oraccelerating osseo-integration of endosseous dental implants, comprisingallowing a heavy force to be exerted on one or more teeth of a patientin need thereof and extra-orally or intra-orally administering aneffective amount of light to the maxillary or mandibular alveolar boneof the patient, where the light is administered before, during or afterthe heavy force is exerted. In other embodiments, the methods compriseintra-orally administering to a patient in need thereof an effectiveamount of light to a region of the patient's maxillary or mandibularalveolar bone. In one embodiment, these methods can be performedaccording to the teachings disclosed herein for the methods forregulating tooth movement.

In some embodiments, the present methods can further comprise applying asubstance to a region, or in the proximity of a region, before, during,or after the administration of light. In some embodiments the methodscan exclude the application of a substance to a region, or in theproximity of a region, before, during, or after the administration oflight, or before, during, or after the exertion of heavy forces. In someinstances, a substance can already occur at a region naturally. In someembodiments, the methods can optionally comprise applying a substance toat least a portion of the face overlying a region before, during, orafter the administration of light. In some embodiments the methods forregulating tooth movement can exclude the application of a substance toat least a portion of the face overlying a region before, during, orafter the administration of light. Optionally, light can be administeredbefore, during, or after the administration of a substance. In someembodiments, light is administered only without the administration of asubstance. The substance can enhance or inhibit the effects of the lightadministration. In one embodiment, the substance can be a visible-light-or infrared-light-absorbing substance, such as a dye. One or more lightcharacteristics, such as wavelength, can be selected in response to thepresence or application of the substance.

Light Therapy Systems

An aspect of the invention relates to light-therapy apparatuses. Thelight-therapy apparatuses are useful for providing light and,accordingly, useful in the present methods; for regulating movement ofteeth; for reducing, minimizing or preventing tooth-root resorption; forreducing, minimizing or preventing bone resorption or inflammatorydentin or cementum resorption of a tooth root or periodontium; forreducing, preventing or minimizing inflammation of tissue surroundingone or more teeth upon which heavy forces are or were exerted; forperforming craniofacial surgery; for performing oral or maxillofacialsurgery; for performing orthognathic surgery; for bone regeneration; orfor treating or preventing jaw osteonecrosis, periodontitis, ormalocclusion. Apparatuses and systems as described herein can also beapplied to treat a variety of conditions including: conditions treatedby orthodontics, application of heavy forces to one or more teeth,stimulation and acceleration of healing after oral surgery orperiodontal surgery, stimulation of the healing of wounds at thelocations of bone grafts, healing and acceleration of osseo-integrationof endosseous dental implants; or any other applications as describedelsewhere herein. In one embodiment, the application to jawosteonecrosis permits treatment of a condition for which existingtreatments are highly invasive. Treating osteonecrosis using lighttherapy is significantly more cost-effective and comfortable for thepatient than existing surgical treatment options. A light-therapyapparatus useful for methods of regulating tooth movement and othermethods described herein, can have other effects. For example,extra-oral application of light on the condylar portion of the mandiblecan increase the growth of the mandible in orthopedic expansion andgrowth treatments.

A light therapy system is provided and comprises a light-therapyapparatus. A light therapy system can also optionally comprise an oralappliance, such as an orthodontic appliance, or oral or tooth mask. Anyorthodontic appliance, as described anywhere above, can be part of thelight therapy system. An oral or tooth mask can block or partiallyfilter one or more wavelength of light from a region covered by themask. For example, a tooth mask can cover one or more teeth. The toothmask can cover one or more mandibular or maxillary tooth. An oral maskcan cover any region of the mouth. For example, an oral mask can coverone or more teeth, or one or more portion of the gums. An oral mask ortooth mask can be formed of a transparent, translucent, or opaque. Anoral mask or tooth mask can block all wavelengths, reduce the intensityof all wavelengths, filter only some wavelengths, or reduce theintensity of only some wavelengths. In some embodiments, an oral mask ortooth mask can alter one or more light characteristics.

A light therapy system can also optionally include an externalcontroller or a computer (or any other device described below) incommunication with a controller.

Any embodiments of a light-therapy apparatus as described herein can beincorporated within the light therapy system. The light-therapyapparatus can optionally comprise one or more support features that canengage with a portion of a patient's face or head. In another embodimentthe light-therapy apparatus engages with the mouth of the patient. Thelight-therapy apparatus can also comprise one or more light sources,wherein the one or more light sources can each comprise one or morelight emitters. The light therapy system can also comprise a controllerthat controls the operation of the light-therapy apparatus. Thecontroller can control the wavelength, intensity or duration of lightemitted by the light-therapy apparatus or the position of itscomponents. The controller can control any other light characteristics.The controller can be integral to or separate from the light-therapyapparatus. The light therapy system provides light and, accordingly, isuseful in the present methods.

In some embodiments, a light therapy system comprises one or more otherappliances. For example, an orthodontic appliance can be applied withinan oral cavity of the patient. In another embodiment, an oral mask ortooth mask can be applied within the oral cavity of the patient. A lighttherapy system can include oral appliances or inserts that are withinthe oral cavity of the patient.

The light-therapy apparatus can be fixed or movable with respect to theorthodontic appliance, oral or tooth mask, or any other appliance.

An embodiment of an orthodontic light-therapy apparatus 20 is shown inFIGS. 1-4. FIG. 1 is an isometric view of an embodiment of alight-therapy apparatus useful for providing light to one or morespecified regions of a patient's maxillary or mandibular alveolar bone.FIG. 2 is a front view of the embodiment shown in FIG. 1. FIG. 3 is atop view of the embodiment shown in FIG. 1. FIG. 4 is a right isometricview of the embodiment shown in FIG. 1. The light-therapy apparatus canbe useful for providing light to any region described anywhere above.

Light-therapy apparatus 20 has a frame 22 which is sized and shaped toengage with one or more features of a patient's face. Features of apatient's face can include, but are not limited to, the patient's ears,nose, nostrils, mouth, lips, chin, jaw, cheek, brow, or forehead. Thelight-therapy apparatus 20 can have a frame 22 that optionally engageswith other features of a patient's head or portion of their anatomy. Forexample, the frame can engage with the crown of the patient's head, thetop or back of the patient's head, the neck, or shoulders.

In the illustrative embodiment illustrated in FIGS. 1-4, frame 22 isshaped to provide ear-engaging portions 24, a nose-engaging portion 26,and support arms 28. A frame can engage with features of a patient'sface by conforming to the shape of the feature, wrapping around thefeature, overlying the feature, grasping the feature, adhering to thefeature or providing pressure or weight to the feature. In someembodiments, frame 22 is formed as an integral unit. In otherembodiments, frame 22 is formed from two or more separate pieces ofmaterial, which are suitably joined to provide frame 22. In someembodiments, frame 22 includes more than one type of material; forexample, support arms 28 can be made from a material that is differentfrom other portions of frame 22. Alternatively, the frame 22 can beformed of the same type of material.

Support arms 28 can be disposed so that they are overlying andcontacting a patient's face, directly over the patient's jawbone whenlight-therapy apparatus 20 is worn in a use configuration by a patient.Portions 24 and 26 facilitate retention of light-therapy apparatus 20 onthe facial area of a patient, while support arms 28 support a pluralityof light sources 30 (also shown as light sources 30A-30H in somefigures), as described below. Support arms 28 can also facilitateengagement of light-therapy apparatus 20 on the facial region of apatient, e.g., by providing a biasing force inwardly against a patient'sface. Other suitable configurations of frame 22 in addition to theillustrated embodiment are useful for securing light-therapy apparatus20 to a patient's face and to support light sources 30 at the desiredlocations and with the desired orientations. The frame can support oneor more light sources so that they contact the patient's face. The framecan be positioned so that the light source contacts the skin of aportion of the face overlying the region.

The frame 22 can include one or more support arms 28 that can be formedof an elongated portion. The support arms can be straight, curved, orbent in order to engage with a patient's face as desired. In someinstances, the frame 22 includes other shaped portions that can includesurfaces that can be flat, curved, or bent, that can cover one or moreportion of the face. In one embodiment, the frame 22 can be curved overthe bridge of a patient's nose, or curved around their ears. The framecan curve around the mouth or around a portion of the mouth.

FIG. 2 provides an example of a frame 22 where four elongated supportarms extend around the mouth. For example, one, two or more support armscan be provided below the mouth. The support arms can be configured tolie over the patient's face, directly above the patient's jaw. One, twoor more elongated support arms can be provided above the mouth or belowthe nose. The support arms can form two tracks, an upper track above themouth, and a lower track below the mouth. In another embodiments, onlyone track is provided, which can be above the mouth, below the mouth, orin line with the mouth. Alternatively, additional tracks can beprovided; for example, multiple support arm tracks can be provided abovethe mouth, below the mouth, or in line with the mouth. The support armscan lie over a right side or a left side of the patient's face. In someembodiments, an elongated support arm can form a continuous piece lyingover both a right side and left side of a patient's face. Alternatively,separate elongate portions can be provided for a right side and leftside of a patient's face. Elongate portions can optionally overly acentral region of the patient's face. In some embodiments, elongateportions do not overly a central region of the patient's face. Anydescription herein of elongated support arms can also apply to supportarms or other portions of the frame 22 that can have other shapes. Anyarrangement of support arms can be applied to any of the light-therapyapparatus embodiments described herein.

In some embodiments, a support arm can include a support feature. Insome embodiments, at least one of a right side of the support or leftside of the support can comprise a support feature. In some embodiments,both the right and left side of the support can comprise supportfeatures. A support feature can allow one or more component of thelight-therapy apparatus to removably engage with the support. In someembodiments, the support feature can allow the one or more components tomove relative to the support while being engaged with the support. Insome embodiments, the one or more components can comprise a lightemitter, a light source, a secondary support, a hinge, or a lightassembly. The support feature can be a track. In some embodiments, atrack can include a slot, channel, groove, or other female feature whichcan be configured to accept a protrusion, ridge, or any other malefeature, which can be provided on a component, such as a light source, asecondary support, a hinge, or a light assembly. In one embodiment, thetrack can be formed on an inner surface portion of the support (e.g.,side of the support closer to a patient's face when in use).Alternatively, the track can be provided on an outer surface portion ofthe support (e.g., side of the support further from the patient's facewhen in use). In some embodiments, the track can be provided through thesupport. Alternatively, a support feature, such as a track, can havemale features that can engage with a female feature of a component.Interlocking features can be provided between the support and one ormore component.

FIGS. 8A-8D show another embodiment of a light-therapy apparatus 80. Thelight-therapy apparatus 80 can have a frame 82 which is sized and shapedto engage with features of a patient's face. The frame 82 can optionallybe shaped to engage with features of a patient's head or another portionof the patient's anatomy. Alternatively, the frame 82 is not shaped toengage with other features of the patient's head or other portions ofthe patient's anatomy.

In some embodiments, the frame 82 can be shaped to provide ear engagingportions, a nose engaging portion 86, and support arms 88. In someembodiments, the frame 82 can be formed as an integral unit. Forexample, the ear engaging portions, the nose engaging portion, and thesupport arms can be formed of a continuous integral unit. In oneinstance, the ear engaging portions, the nose engaging portion, and thesupport arms can form a single continuous elongated piece. In otherembodiments, frame 82 can be formed from two or more separate pieces ofmaterial, which are suitably joined to provide frame 82. In someembodiments, one support arm per side of the face can be provided.Alternatively, multiple support arms per side of the face can beprovided. One or more support arm can be engaged with the nose engagingportion or ear engaging portion.

Support arms 88 can be disposed so that they are adjacent to a patient'sface overlying the jawbone or so that they are in the proximity of apatient's jawbone when light-therapy apparatus 80 is worn in a useconfiguration by a patient. In some embodiments, the support arms can bepositioned so that one more light source 81 can contact the patient'sface over the patient's jawbone or contact any other selected region ofa patient's face. Portions, such as an ear engaging portion, noseengaging portion 26, or any other portion of a frame that can engagewith features of a patient's face, can facilitate retention oflight-therapy apparatus 80 on the facial area of a patient, whilesupport arms 88 supports one or a plurality of light sources 81 (alsoshown as light sources 81A-81D in some figures), as described below.Support arms 88 can also facilitate engagement of light-therapyapparatus 80 on the facial region of a patient, e.g., by providing abiasing force inwardly against a patient's face. Other suitableconfigurations of frame 82 in addition to the illustrated embodimentcould be used to secure light-therapy apparatus 80 to a patient's faceand to support light sources 81 at the desired locations and with thedesired orientations. Other features, configurations, or components, asdescribed in other embodiments, can be incorporated within thisembodiment.

A frame, for any embodiment of a light-therapy apparatus, can beconstructed from any suitable material; for example, lightweightplastic, steel, aluminum, copper, copper clad materials (such asaluminum or steel), nickel, titanium, silver, iron, other suitable metalor plastic, tubular plastic, plastic composite embedded with metalparticles, graphite, graphite-epoxy, or any combinations or alloysthereof. The frame or portions of frame can optionally include a resincovering or suitable padding to cushion a patient's face. The frame canbe made from flexible material, or from material which is thermallyconductive. If a frame is made from a thermally conductive material suchas, for example, aluminum, the frame can be capable of dissipating heatfrom one or more light sources, described below.

A frame can be made from a material which provides the frame withflexibility or which permits the frame to be conformed to the anatomicalfeatures of a particular patient's face. The frame or other componentsof the light-therapy apparatus can be bent in one or two dimensions.They can be moldable to conform to contours of the patient's face. Aphysician, dentist, orthodontist, therapist, technician or otherindividual, including a patient, can initially “fit” a particularlight-therapy apparatus to a particular patient by adjusting andconforming that particular light-therapy apparatus to the anatomicalfeatures of that particular patient to provide an individualized fit.The material of which the frame is constructed can be sufficientlyresilient to retain the individualized fit over the course oforthodontic therapy for that particular patient, and yet sufficientlyflexible to permit that particular light-therapy apparatus to bere-adjusted (e.g. in response to complaints of discomfort from apatient) or adjusted to fit a different patient.

Any description, components, features, details of an embodiment of alight-therapy apparatus can be applied to any other embodiment of alight-therapy apparatus, and vice versa. For example, modifications toany device of FIGS. 1-4 (e.g., a frame 22 or light source 30 as providedin FIGS. 1-4) can be made to any of FIGS. 8A-8D (e.g., frame 82 or lightsource 81 in FIGS. 8A-8D), FIG. 9, FIG. 14, FIG. 17, or FIG. 18.

Providing a flexible frame 22 can also facilitate light source 30contacting the cheek of a patient by support arms 28 (i.e., support arms28 can bias light source 30 against the desired region of lightadministration on a patient's face, directly over his or her jawbone).In some embodiments, the morphology of the frame or the support arms,can cause the light source to contact a portion of a patient's face whenthe light-therapy apparatus is in use, e.g., when the light-therapyapparatus is worn by a patient. Other features can bias the lightsource, e.g., by providing pressure, to contact a portion of thepatient's face, including but not limited to, elastic components,springs, inflatable portions, moving mechanical portions. Such bias canbe provided when the patient's face is relaxed or when the patient'sface is tensed. Bias of light source 30 on the cheek of a patient candepress the soft tissue, which can increase the effective transmissionof light through the tissue. Thus, in some embodiments, it can bedesirable for a light source to contact the skin of a patient's face ordepress the skin of the patient's face.

In other embodiments, a gap can be provided between a light source and askin of the patient's face. The frame can be configured to provide thegap between the light source and the patient's face. The light sourcecan be in close proximity to the skin of the patient's face withoutcontacting the patient's face. In some embodiments, the light sourcedoes not contact a patient's face when the patient's face is relaxed butcan contact the face if the patient flexes a portion of the patient'sface or tenses the face. In some embodiments, a light source can beabout 1 mm or less, 2 mm or less, 3 mm or less, 5 mm or less, 7 mm orless, 1 cm or less, 1.5 cm or less, 2 cm or less, 2.5 cm or less, 3 cmor less, or any distance described anywhere above, away from a patient'sface while the patient's face is relaxed.

In some embodiments, the light source can contact a translucent ortransparent material, such as a gel or solid film that contacts thepatient's face. The frame can be configured so that the translucent ortransparent material contacts the patient's face when the apparatus isin use. In some embodiments, the light source can include an exteriorsurface formed of a translucent or transparent material, such as a gelor solid film that contacts the patient's face. One or more lightemitters of the light source can contact that exterior surface.Alternatively, a gap can be provided between the light emitters and theexterior surface. In some embodiments, the translucent or transparentmaterial filters light of one or more particular wavelengths. In someother embodiments, the material dissipates heat generated by operationof the light source.

In some embodiments, a light emitter provided on a light source can bepositioned at a distance from a region. The frame can be configured sothat the light source is at a distance from the region. The region canbe within a patient's oral cavity. In some embodiments, the lightemitter can be provided external to the oral cavity. A portion of apatient's face, such as the cheek, lips, or chin can be lie between thelight emitter and the oral cavity when the device is in use. A lightemitter can be positioned at about 0.1 mm or less, about 0.5 mm or less,about 1 mm or less, about 2 mm or less, about 3 mm or less, about 5 mmor less, about 7 mm or less, about 1 cm or less, about 1.5 cm or less,about 2 cm or less, about 2.5 cm or less, about 3 cm or less, or anydistance described anywhere above, from a region.

Optionally, regions of greater flexibility than the remainder of framecan be provided between light sources or at other suitable locations onframe, to allow frame to be bent to provide a better fit around thefacial area. Regions of greater flexibility can be provided, forexample, by forming the region of greater flexibility from a portion ofmaterial that is thinner than the remainder of frame, by forming theregion of greater flexibility from a material that is more flexible thanthe remainder of frame, or by providing hinge-like members (e.g., a thincrease or other bend line set into the material of which frame isconstructed) within the frame. Other examples of how flexibility can beprovided, can include using a bendable material, using a stretchableelastic material, using a spring, including multiple components that canslide or move relative to one another, that can unfold relative to oneanother, using telescoping features, including one or more joint (e.g.,ball and socket, hinges), or having parts that can lock to one anotherat different size options. The frame can be adjustable to fit patientswith different sized or shaped heads. In some instances, a frame sizecan be selected based on the size or shape of a patient's head.

In some embodiments, at least one light source 30 is secured to frame 22in order to emit light towards a patient when light-therapy apparatus 20is in the use position. Light source 30 is disposed extra-orally, i.e.,outside of a patient's oral cavity, when light-therapy apparatus 20 isin the use position. When in use, the light source irradiates throughthe skin of a patient's face. Light can reach a region that is within apatient's oral cavity by transcutaneously irradiating through the skin.In some embodiments, when in use, light from a light source 30 is notconfigured to directly irradiate into the oral cavity, and reaches theoral cavity only through the skin. In one embodiment, light can reach aregion only transdermally.

A light-therapy apparatus can have one or more light source capable ofemitting light in the wavelengths described below or described anywhereabove. The light provided by the light source is not necessarily visiblelight—any desired wavelength can be used. For example, light emitted bythe light source can include infrared light or near-infrared light. Thelight source can also irradiate in the visible light region. Forexample, the light source can be configured to irradiate light fallingwithin or ranging from about 400 nm to about 1200 nm. In particularembodiments, the light source can be configured to irradiate lightfalling within or ranging from about 500 to about 700, about 585 nm toabout 665 nm, about 605 nm to about 630 nm, about 620 nm to about 680nm, about 815 nm to about 895 nm, about 815 to about 895 nm, about 820nm to about 890 nm, about 640 nm to about 680 nm, or about 740 nm toabout 780 nm. In some embodiments, the wavelengths can fall within orrange from about 605 nm to about 645 nm, or from about 835 nm to about875 nm. In some embodiments, the wavelengths can fall within or rangefrom about 615 nm to about 635 nm, or from about 845 nm to about 865 nm.In some embodiments, the wavelengths can be about 625 nm or about 855nm. In some embodiments, a light source can be configured to emit lightat one, two, or more of the light ranges described. In some instances, alight source does not emit light outside one, two, or more of the lightranges described. In other embodiments, light emitters can be configuredto irradiate light having other wavelengths, as desired for a particularapplication. Light can be emitted at any of the wavelengths describedanywhere above.

In some embodiments a light source can be capable of emitting light atone, two, or more peak wavelengths of emission. A peak wavelength can bethe wavelength at which the highest intensity of light is emitted. Insome embodiments, light can be emitted at a range of wavelengths and thepeak wavelength can be the wavelength with the highest intensity withinthe range. In some embodiments, a peak wavelength can be provided atabout 620 nm, about 640 nm, about 650 nm, about 655 nm, about 660 nm,about 665 nm, about 670 nm, about 680 nm, about 690 nm, about 800 nm,about 820 nm, about 830 nm, about 835 nm, about 840 nm, about 845 nm,about 850 nm, about 860 nm, about 870 nm, or about 890 nm. The light canhave any other wavelength characteristics as described anywhere above.

A light source can be any suitable light source, which can include one,two, three, four, five, six, seven, eight, or more light emitters. Insome embodiments, a light source comprises about 10 to about 15emitters, about 15 to about 20 emitters, about 20 to about 30 emitters,about 30 to about 40 emitters, about 40 to about 50 emitters, about 50to about 70 emitters, or about 70 emitters to about 100 emitters. Forexample, a light source can comprise a light-emitting diode (LED) (e.g.,gallium arsenide (GaAs) LED, aluminium gallium arsenide (AlGaAs) LED,gallium arsenide phosphide (GaAsP) LED, aluminium gallium indiumphosphide (AlGaInP) LED, gallium(III) phosphide (GaP) LED, indiumgallium nitride (InGaN)/gallium(III) nitride (GaN) LED, or aluminiumgallium phosphide (AlGaP) LED), which can be present in an array; or alaser, for example a vertical cavity surface emitting laser (VCSEL) orother suitable light emitter such as anIndium-Gallium-Aluminum-Phosphide (InGaAIP) laser, a Gallium-ArsenicPhosphide/Gallium Phosphide (GaAsP/GaP) laser, or aGallium-Aluminum-Arsenide/Gallium-Aluminum-Arsenide (GaAIA5/GaAs) laser.In one embodiment the light source comprises a plurality of lasers. Aplurality of light emitters capable of emitting light at severaldifferent wavelengths can be used for light source 30. Alternatively,one or more light emitters capable of emitting light at the samewavelength can be used for the light source. One or more light emitterscan be arranged on a light source in any manner. For example, aplurality of light emitters can be arranged in one or more rows orcolumns. The rows or columns can form an array, or a staggered set ofrows or columns, concentric shapes. Light emitters can be provided fromany commercially available source, and can include but are not limitedto Optowell XH85 vcsel, ULM Vcsel, or Osram MIDLED.

A light source 30 can be of any size and shape useful to irradiatethrough a patient's face a specified region of the patient's maxillaryor mandibular alveolar bone. For example, in some embodiments, the lightsource 30 can have a height of about 9-10 mm along a vertical axistangential to a patient's face, and a width in the range of about 15-18mm along a horizontal axis tangential to a patient's face, as measuredwhen light-therapy apparatus 20 is in the use configuration. One or moredimensions of a light source range from about 1-70 mm. In someembodiments, one or more dimensions of a light source range from about1-3 mm, about 3-5 mm, about 5-7 mm, about 7-10 mm, about 10-15 mm, about15-20 mm, about 20-25 mm, about 25-30 mm, about 30-35 mm, about 35-40mm, about 40-50 mm, or about 50-60 mm.

A light source can have any shape, which can include, but is not limitedto, a substantially rectangular shape, square shape, triangular shape,hexagonal shape, octagonal shape, trapezoidal shape, circular shape,elliptical shape, crescent shape, cylindrical shape or half-circle. Alight source can have rounded or pointed corners. In some embodiments,the dimensions of a light source can be about the same as dimensions fora region area. In other embodiments, the dimensions of a light sourcecan be greater than the dimensions of a region area. Alternatively, thedimensions of a light source can be less than the dimensions of theregion area. The relative areas of a light source and region can dependon a parallel, convergence, or divergence angle at which light isemitted.

In some embodiments, each of the light sources within a light-therapyapparatus can be the same size or shape. In other embodiments, the lightsources can have different sizes or shapes. Light source size or shapecan be selected to administer a desired distribution of light to aregion. A light source can have one type of light emitter.Alternatively, a light source can have two, three, four, five, or moredifferent types of light emitters. Each light source can have adifferent light emitter or combination of light emitters, or can havethe same light emitter or combination of light emitters. For example,each light source can have LEDs emitting light within the range of about585 nm to about 665 nm, and LEDs emitting light within the range ofabout 815 nm to about 895 nm. In another embodiment, a first lightsource can have LEDs emitting from about 585 to about 665 nm, while asecond light source can have LEDs emitting from about 815 to about 895nm.

In some embodiments, one or more light source can include a substratesupporting the one or more light emitters. For example, one or morelight source can comprise an array of light emitters mounted on aflexible sheet of material that will hold a shape when it is bent. Theflexible material can advantageously comprise a metal sheet that canserve as a heat sink or thermal path to a heat sink. The flexible sheetcan be molded to conform to the contours of a patient's face while thelight-therapy apparatus is being fitted or is in use. The substrate canalso include a cushioned material that can contact a patient's facewithout causing discomfort.

In some embodiments, light emitters of different characteristics (e.g.,wavelength, intensity, pulsing, size), can be provided for a lightsource. In some instances, the different light emitters can be evenlyinterspersed within a light source. For example, light emitters of afirst wavelength can be evenly interspersed within light emitters of asecond wavelength. Alternatively, different light emitters can belocalized. For example, light emitters of a first wavelength can beprovided within a first region of a light source, and light emitters ofa second wavelength can be provided within a second region of the lightsource.

A plurality of light sources 30 can be disposed on frame 22 toadminister light of the desired wavelength substantially uniformly todesired regions of a patient's face, so as to irradiate, in oneembodiment through the face, the patient's maxillary or mandibularalveolar bone, or any other region as described elsewhere herein. Anynumber of light sources can be disposed on a frame. For example, one,two, three, four, five, six, seven, eight, nine, ten, eleven, twelve,thirteen, fourteen, fifteen, sixteen, seventeen, eighteen, nineteen,twenty, or more light sources can be provided for a light-therapyapparatus. The light sources can be distributed along any portion of theframe. In some embodiments, the same number of light sources can beprovided on the right side and the left side of the frame.Alternatively, different numbers of light sources can be provided theright and left sides of the frame. One, two, three or more light sourcescan be positioned to administer light to a region. In some embodiments,the light administered by light sources to a particular region can bethe same for each light source, or can vary.

One or more of the light sources can be removable. In some embodiments,all of the light sources are removable, while in other embodiments, oneor more of the light sources are not removable. In some instances, noneof the light sources are removable. Different types of light sources canbe used to provide a desired light with a desired distribution to aregion. For example, different light sources can be used for differentapplications, such as different stages of orthodontic treatment. Forexample, a first light source providing light at a first wavelengthrange can be used for one purpose, and a second light source providinglight at a second wavelength range can be used for the same or for adifferent purpose. Or a first light source having a first size or shapecan be used instead of or in conjunction with a second light sourcehaving a second size or shape. Additional light sources can be added orremoved. Different light sources can be added or removed during thecourse of a treatment, such as an orthodontic treatment, boneregeneration treatment, or any of the other treatments disclosed herein,or during the course of preventing one or more abnormal conditionsdisclosed herein.

Each individual light source 30 can be separately configured orseparately controllable, to provide light of a specified wavelength orintensity to a specific region of a patient's jawbone, or any otherregion for a desired period. In one embodiment the light is providedthrough the patient's face.

In some instances, one or more groups or subgroups of light sources canbe separately configured or separately controllable, while all lightsources belonging to the group or subgroup provide light of the samewavelength or intensity. In another implementation, all light sourcesbelonging to a light-therapy apparatus can be controlled together.

In some embodiments, a light-therapy apparatus can be configured toadminister light to only some regions of the patient's maxillary ormandibular alveolar bone, if it is desired that teeth in other regionsdo not need to be moved (e.g. it can be desired to move only the upperteeth of a patient, or only the lower teeth, or to use certain teeth asan anchor when moving other teeth by administering no light to theanchor teeth). The light-therapy apparatus can also be capable ofproviding light of different wavelengths to different regions of thepatient's maxillary or mandibular alveolar bone, if it is desired todifferentially manipulate the movement of a patient's teeth, asdescribed below. For example, light of a first wavelength can beadministered to a first region and light of a second wavelength can beadministered to a second region. The first and second wavelengths caninclude any wavelengths described elsewhere herein, such as about 585 nmto about 665 nm, and about 815 nm to about 895 nm, respectively.

In some embodiments, light can be administered to a region that caninclude a portion of tissue (e.g., bone tissue, or soft tissue) or otherregions within the patient's oral cavity without being administered toother portions of the patient's oral cavity. In some embodiments, lightcan be administered to a region that can include a portion of tissue(e.g., bone tissue, or soft tissue) or other regions within thepatient's oral cavity at a much greater intensity than it isadministered to other portions of the patient's oral cavity. Forexample, 3×, 5×, 10×, 20×, 50×, or 100× greater intensity of light canbe administered to a region, than another portion of the patient's oralcavity. In some embodiments, this is achieved by applying to the patientone or more intra-oral or extra-oral light-translucent or light-opaquemasks that shield from light one or more non-regions. In someembodiments, light reaching a region can have an intensity that isgreater than a threshold value. In some embodiments, the threshold valuecan be at an intensity as described elsewhere herein.

A patient can position light-therapy apparatus 20 herself or himself toaccurately and repeatedly illuminate a desired location in the patient'sdental and maxillofacial areas when light-therapy apparatus 20 is in ause position. Consistent positioning of light-therapy apparatus 20during the course of a patient's treatment can make therapy moreeffective and repeatable, and ease of use of light-therapy apparatus 20can facilitate patient compliance with a given treatment regimen.

In the embodiment illustrated in FIGS. 1-4, a plurality of light sources30A, 30B, 30C, 30D, 30E, 30F, 30G, and 30H are disposed at symmetricallocations about frame 22. In other embodiments, a plurality of lightsources 30 can be disposed asymmetrically about frame 22, the positionof light sources 30 on frame 22 can be adjustable, or one or more thanone light source 30 can be removable, to permit light-therapy apparatus20 to be configured to administer, in one embodiment through thepatient's face, light to a specific region or regions of a patient'smaxillary or mandibular alveolar bone. For example, each light source 30can be configured to illuminate the bone surrounding a specific numberof teeth, for example two or three teeth, at a specific location.

In use, light is emitted from an inner surface 32 of one or more lightsource 30 extra-orally towards a desired area. As used herein, the term“inner surface” refers to the surface of an element that is closest tothe facial regions of a patient when light-therapy apparatus 20 is inthe use position. Inner surface 32 can have rounded edges 33, as shownfor example in FIGS. 7A and 7B, and can include a clear resin windowcovering the light emitters, to provide greater comfort for a patientwhen light-therapy apparatus 20 is in the use position and when thelight emitter's contact the patient's face.

Any suitable light emitter can be used for the one or more light source30. In some embodiments, light is emitted by arrays of discrete LEDs.The LEDs can be arranged in any of a wide variety of patterns. Forexample, the LEDs can be arranged in staggered parallel rows to maximizethe density of LEDs in the LED array. The LEDs can be arranged toachieve substantially uniform optical intensity over the light-emittinginner surface 32 of one or more light source 30. Alternatively, the LEDscan be clustered or distributed to provide varying optical intensitiesover an area of a light source. In some embodiments, each array cancomprise 5 to about 20 LEDs or other light emitters. In someembodiments, each array can comprise about 20 to about 50 or more LEDsor other light emitters. In other embodiments, light from one or morelight source 30 can be emitted by one or more than one VCSEL. Aplurality of VCSELs can be disposed in an array on a light source 30.The VCSELs can be disposed in aligned or staggered parallel rows. Inanother embodiment, a combination of different types of light emitters,such as LEDs and VCSELs can be provided for the same light source.

A light-therapy apparatus can be configured to provide light with adesired light intensity. In one embodiment the average light intensityproduced by a light source 30 is at least about 10 mW/cm². In otherembodiments, the average light intensity produced by a light source isbe about 1 mW/cm² or greater, about 3 mW/cm² or greater, about 5 mW/cm²or greater, about 7 mW/cm² or greater, about 12 mW/cm² or greater, about15 mW/cm² or greater, about 20 mW/cm² or greater, about 30 mW/cm² orgreater, about 50 mW/cm² or greater, about 75 mW/cm² or greater, about100 mW/cm² or greater, about 200 mW/cm² or greater, about 500 mW/cm² orgreater, or about 1 W/cm² or greater. In other embodiments, the averagelight intensity produced by a light source can be about 20 mW/cm² orless, about 30 mW/cm² or less, about 50 mW/cm² or less, about 75 mW/cm²or less, about 100 mW/cm² or less, about 200 mW/cm² or less, about 500mW/cm² or less, about 1 W/cm² or less, or about 2 W/cm² or less. In someembodiments, a light source 30 has an average intensity that is, or canbe adjusted to be, in the range of about 10 mW/cm² to about 60 mW/cm²,or about 20 mW/cm² to about 60 mW/cm². In some embodiments, the outputof light source 30 is pulsed. In such embodiments, the peak lightintensity can be significantly higher than about 50 mW/cm². In otherembodiments, the output of light is continuous. In some embodiments, thelight intensity can vary over time in a cyclical or non-cyclicalfashion. The light intensity can vary with or without pulsing. In someembodiments, the light intensity can vary with pulse width modulation.Any other light intensity described anywhere above can be provided bythe light-therapy apparatus.

The light emitters can be controllable so that the number of lights thatare on or off at a given period can be individually controllable. Forexample, each light emitter can be on or off relative to other lightemitters. This can be desirable when it is desirable to administer lightto different regions. Thus, the light-therapy apparatus can alter theposition of light being administered. In another embodiment, each lightemitter can be on or off relative to other light emitters. For example,at some times, light emitters emitting in a first wavelength range canbe on while light emitters emitting in a second wavelength range can beoff, vice versa, or both types of light emitters can be on or off. Thus,the wavelength of light being administered can be varied. In someembodiments, the intensity of light being administered can be varied(e.g., by turning some light emitters on or off, or varying theintensity emitted by the light emitters). If the light emitters arepulsed, their duty cycle can be adjustable; e.g., light emitters can becapable of having a duty cycle of about 10%, about 20%, about 30%, about40%, about 50%, about 60%, about 70%, about 80%, or about 90%. The lightemitters can be capable of pulsing can occur with any frequency. Forexample, light emitters can be pulsed on the order of every picosecond,nanosecond, microsecond, millisecond, second, multiple seconds, orminutes. Light emitters can provide light with frequencies of about 1mHz, about 10 mHz, about 50 mHz, about 100 mHz, about 500 mHz, about 1Hz, about 2 Hz, about 5 Hz, about 10 Hz, about 15 Hz, about 20 Hz, about25 Hz, about 30 Hz, about 35 Hz, about 40 Hz, about 50 Hz, about 70 Hz,about 100 Hz, about 200 Hz, about 500 Hz, or about 1 kHz. Thelight-therapy apparatus can be controllable so that any of theaforementioned characteristics of light emission (e.g., whether thelight is on or off, continuous or pulsed, duty cycle, frequency,intensity, wavelength) can be varied or maintained in accordance withinstructions from a controller.

The light-therapy apparatus can be capable of emitting light withvarying intensities. Any ratio of intensities can be provided for lightemitted at any of the wavelengths. For example, light emitted at a firstwavelength can have about a 1.1×, 1.2×, 1.3×, 1.5×, 1.7×, 2.0×, 2.5×,3.0×, 3.5×, 4.0×, 5.0×, 10×, 12×, 15×, 20×, 30×, 50×, 100× intensitycompared to a light emitted at a second wavelength. In some embodiments,the same number of light emitters having a first set of characteristicsand a second set of characteristics can be provided. In otherembodiments, more light emitters having a first set of characteristicscan be provided than light emitters having a second set ofcharacteristics. For example, about 1.1×, 1.2×, 1.3×, 1.5×, 1.7×, 2.0×,2.5×, 3.0×, 3.5×, 4.0×, 5.0×, 10×, 12×, 15×, 20×, 30×, 50×, 100× lightemitters having the first set of characteristics can be provided aslight emitters having the second set of characteristics.

One or more light source 30 can include optical elements such as one ormore lenses or reflectors to focus and direct light from the lightsource 30 onto a selected area. Any type of optical lens or reflectorcan be used. For example, an optical lens can be used to collimate thelight, diffuse the light, or focus the light. In some embodiments, oneor more Fresnel lenses or telecentric lenses can be used. Any type ofreflector can be used. A lens can be provided to cause light divergence,or light convergence. For example, one or more mirrors can beincorporated. The mirrors can be used to assist with scattering,redirecting, or focusing the light. Such optical elements can besuitably encapsulated in plastic or similar material, which can betransparent, translucent or opaque. The plastic or other encapsulatingmaterial can form an exterior surface of a light source. The lightemitters or optical elements can be provided within an interior portionof the light source. Alternatively, encapsulating materials need notprovided, and the optical elements or the light emitters can be providedas an exterior surface of a light source. In some embodiments, there canbe a gap between a light emitter and an encapsulating material. A gapcan exist between a light emitter and an exterior surface of the lightsource.

An exterior surface of a light source can contact a patient's face. Forexample, an encapsulating material for a light source can contact apatient's face. In other examples, optics, such as a lens optionallycontacts the patient's face. In some embodiments, a light emitter cancontact the face directly, while in other embodiments, the light emitterdoes not contact the face directly.

FIG. 5 shows a portion of a light source 30. In the illustratedembodiment, a light emitter 38 (which can, for example, comprise ajunction in a light-emitting diode or other light-emitting semiconductordevice) is located adjacent to a reflective backing 40. A curvedlight-reflecting recess 42 is provided adjacent to light emitter 38.Light from light emitter 38 is reflected in recess 42 to form a beam.The beams from all light emitters of a light source 30 can combine toilluminate the selected tissues. The area covered by the beam willdepend upon the tissues which it is desired to treat. In someembodiments, the beam of light emitted by a light source 30 diverges tocover an area of tissue larger than the area of the light-emitting partof a light source 30. In other embodiments the emitted light convergesto provide increased light intensity at the location of the tissues thatit is desired to treat. In some embodiments, the emitted light divergesin a beam having an included angle θ in the range of about 45° to about60°. The emitted light can form a diverging to have an included angle θof 0° to about 15°, 0° to about 30°, 0° to about 45°, 0° to about 60°,0° to about 75°, 0° to about 90°, or 0° to about 120°.

Since LEDs and other light emitters can emit heat when they areoperated, it can be desirable to provide a suitable mechanism fordissipating the heat to prevent any parts of light-therapy apparatus 20that are proximate to a patient's skin from getting too hot. In someembodiments, heat is dissipated by passive cooling, such as, forexample, provision of appropriate heat sinks or permitting air to flowfreely around light sources 30. Heat sinks 36 are an example of passivecooling. Heat sinks can be in thermal communication with one or morelight source. In one embodiment, one or more light source can comprisethermally-conductive LED wafers mounted on a suitable heat sink Heatfrom the LED wafers can be conducted into the heat sink and dissipated.

In some embodiments, one or more light source 30 can include a forcedair, liquid, or solid state cooling system. In one embodiment, a heatsink has pins projecting from its face that is away from LED arrays. Afan causes air to flow past pins to carry away excess heat. Otherfluids, such as other gases, or water or other liquids, can be drivenpast the pins to assist with carrying away excess heat.

A cooling system allows for administration of light without the dangerof potential burns to the patient and allows for greater efficiency andcontrol of the apparatus. A cooling system can be installed onlight-therapy apparatus 20 in any suitable manner. The cooling systemcan be in thermal contact with one or more light source. In someembodiments, a cable recess (illustrated as 64A or 64B in FIGS. 7A and7B) can be provided within one or more light source 30 to accommodateaspects of a cooling system or cables that can be used with or form partof light-therapy apparatus 20.

In one embodiment, as shown in FIGS. 8A-8D, a cooling mechanism 83 canbe provided. In one embodiment, the cooling mechanism can contact one ormore light source 81, and can be formed of a conductive material. Thecooling mechanism can conduct heat from the one or more light source anddissipate the heat to the surroundings. The cooling mechanism canfunction as a heat spreader or heat sink. The cooling mechanism can havean increased surface area by including one or more open region 83 adisposed between one or more solid region 83 b. A fluid is optionallyforced through the cooling mechanism.

In one embodiment that can use either passive or active cooling, orboth, support arms 28 can be constructed from milled aluminum, and oneor more light source 30 can be constructed so as to be engageable with atrack formed on the inner surface 34 of support arms 28, as shown forexample in FIG. 7A. One or more light source 30 can be engageable with atrack 60 formed in the inner surface 34 of support arms 28 via atrack-engaging ridge 62A formed on the one or more light source 30.Track 60 and track-engaging ridge 62A can have any suitablecomplementary configuration and orientation to retain one or more lightsource 30 against support arms 28 and oriented toward a wearer's facewhen light-therapy apparatus 20 is in the use position. One or morelight source 30 can be slideable within track 60, to facilitate thepositioning of light source 30. One or more light source 30 canalternatively be coupled to support arms 28 in any other suitablemanner, such as by a clip, clamp, adhesive, thermally conductiveadhesive, hook and loop fastener, or any other connection mechanism. Insome embodiments, one or more light source 30 can be integrally formedwith support arms 28.

In some embodiments, the track can have a fixed position relative to therest of the frame. In one embodiment, a track can be a shaped featurewithin the frame. In other embodiments, the track can be adjustable tothe rest of the frame. For example, the track can be formed of amaterial that can allow a user to bend the track to a desiredconfiguration, and can stay at that configuration. In other embodiments,adjustment features, such as hinges, joints, or other moving parts canallow a user to adjust a track position.

One or more light source can slide along a length of the track.Alternatively, light sources can be attached or removed at differentpoints along the track. In some embodiments, light sources can beattached or removed only at certain locations along the track (e.g.,discrete portions that accept the light sources). Alternatively, one ormore light source can be attached or removed at any point along thetrack. Thus, one or more light source can be displaced.

In some embodiments, one or more light sources can be applied to theframe so that they have a fixed orientation. Alternatively, the one ormore light sources can be rotatable relative to the frame. Depending onthe dimensions of a light source, this can allow variation in the regionreceiving light. One or more light source can be rotatable about one ormore axis. For example, one or more light source can be rotatable abouta first axis that is about parallel, i.e., ranging from +18° to −18° ofbeing parallel, with the support arm, about a second axis that isperpendicular to the support arm, or about a third axis that isperpendicular to both the first and second axis. In some embodiments,one or more light source can be supported by a hinge, pivot, or otherconfiguration that can allow one axis of rotation. In other embodiments,multiple hints, pivots, or other mechanisms can be provided that canallow for two or more axes of rotation. In another embodiment, one ormore light source can be supported by a ball and socket joint that canprovide multiple degrees of freedom. The orientation of one or morelight source relative to the frame can be manually adjusted. A user canturn one or more light source to a desired orientation. Alternatively,the orientation of one or more light source can be remotely controlled.For example, one or more actuator can be provided that can cause one ormore light source to turn to a desired orientation. Actuators canoperate based on a signal received from a controller. The signal can bereceived via a wired connection or wirelessly, as described elsewhereherein.

In another embodiment, as shown in FIGS. 8A-8D, one or more light source81 can be configured to slide along a support arm 88. For example, asupport arm on the right side of the face and a support arm on the leftside of the face can include a track 85 that can enable a light assemblyto slide along the track. The track can be parallel to the support arm.Alternatively, the track can be provided at some non-parallel angle tothe support arm. In some embodiments, the track or support arm can havea substantially horizontal orientation when the apparatus is in use. Alight assembly can include one or more light source 81, temperaturecontrol system 83 or vertical track 87. In some embodiments, one or morelight assembly can be provided on a right support arm or one or morelight assembly can be provided on a left support arm. In someembodiments, a support arm does not include a light assembly. A track ona support arm can be about horizontal, i.e., ranging from +18° to −18°of being horizontal. In alternate embodiments, the track can have anyother orientation, which can include a vertical track, slanted travel,or curved track. In some embodiments, one, two, three, or more trackscan be provided on a support arm. The position of a light assemblyrelative to a support arm can be manually adjusted. For example, a usercan push the light assembly to a desired position along the support arm.Alternatively, the position of the light assembly can be remotelycontrolled. For example, one or more actuator can be provided that cancause the light assembly to move to a desired position. Actuators caninclude, but are not limited to, motors, solenoids, linear actuators,pneumatic actuators, hydraulic actuators, electric actuators,piezoelectric actuators, or magnets. Actuators can cause the lightassembly to move based on a signal received from a controller.

In some embodiments a vertical track 87 can be provided. The verticaltrack can be about perpendicular, i.e., ranging from +9° to −9° of beingperpendicular, to a track along a support arm 88. Any description hereinof the vehicle track can be applied to any other secondary track of anyorientation that can be in communication with a track on a support arm.The vertical track can be adjustable relative to a track on the supportarm. For example, the vertical track can slide along the track along thesupport arm. In some embodiments, the vertical track can be removable orattachable to the support arm, such as on the track along the supportarm. In some instances, the vertical track can be attachable at one ormore location along the support arm. Such locations can be discrete orcontinuous. One, two, three, four, or more vertical tracks can beattachable to the support arm simultaneously. The position of a verticaltrack relative to a support arm can be manually adjusted. For example, auser can push the vertical track to a desired position along the supportarm. Alternatively, the position of the light assembly can be remotelycontrolled. For example, one or more actuator can be provided that cancause the light assembly to move to a desired position. The actuator canrespond to a signal from a controller. The vertical track is optionallyrotatable relative to the support arm. For example, the vertical trackcan be rotatable so that it is no longer vertically oriented, but can behorizontally oriented, or provided at a slant. The vertical track can berotated manually. Alternatively, one or more actuator can be providedthat can cause the vertical track to rotate to a desired position. Theactuator can respond to one or more signal from a controller.

One or more light source 81 can be configured to slide along a verticaltrack. Alternatively, one or more light source can be attachable orremovable from the vertical track at discrete or continuous locations.The position of one or more light source relative to a vertical trackcan be manually adjusted. For example, a user can push one or more lightsource to a desired position along the vertical track. Alternatively,the position of one or more light source can be remotely controlled. Forexample, one or more actuator can be provided that can cause one or morelight source to move to a desired position. One or more light source canhave a fixed orientation relative to the vertical track. Alternatively,it can be rotatable about a first axis, second axis, or third axis, suchas those previously described. One or more light source can be manuallyoriented, or can have an actuator that orients the light source inresponse to a signal received from a controller. In one embodiment, oneor more light source can be attached to a vertical bar 89 that can allowthe light source to rotate about the bar within a limited range. Thiscan allow the light source to have a desired position relative to apatient's face when in use. In one embodiment, two light sources can beprovided along a vertical track. In alternate embodiments of theinvention, the vertical track need not be perpendicular to a support armand vertical. For example, a secondary track can be provided at anyangle relative to the support arm (e.g., at about 15 degrees, about 30degrees, about 45 degrees, about 60 degrees, about 75 degrees, or about90 degrees relative to the support arm). In some embodiments, thesecondary track can have a fixed orientation relative to the supportarm. Alternatively, the secondary track can be rotatable relative to thesupport arm.

In some embodiments, one or more light source can rotate or moverelative to the secondary track. For example, a hinge, pivot, ball andsocket joint, or other type of mechanism can be provided that can allowone or more light source to rotate relative to the second track. In someembodiments, one or more light source can rotate within a limited range.In some embodiments, the relative position of one or more light sourcecan be adjusted manually. For example, one or more light source cancontact a patient's face and the position of the light source canconform to the contours of the patient's face. For example, the relativeangle of the light source can conform to the patient's face. In otherembodiments, one or more actuator can be provided to adjust the positionof one or more light source. An actuator can operate in response to asignal received from a controller. In some embodiments, the position ofone or more light source can be locked so that once a desiredconfiguration for the light source has been set, it is not be adjustedmanually. Alternatively, one or more light source can be responsive toforce, so that a patient or other individual can be able to adjust theposition of the light source.

In some embodiments, a third track, or fourth track can be provided. Inone embodiment, a third track can be provided on a secondary track, or afourth track can be provided on a third track. The support arm cancomprise any number of tracks that provide various degrees offlexibility in the locations of one or more light source. In otherembodiments, the support arm comprises one or more other components orconfigurations which can include but are not limited to bars, notches,slides, elastics, or holes.

A heat sink 36 can interpose one or more light source 30 and innersurface 34 of support arms 28. Heat sink 36 can, for example, be made ofcopper, aluminum, or other suitable thermally conductive material, toenhance dissipation of heat from light source 30. With reference to FIG.7B, heat sink 36 can be engageable with track 60 formed in the innersurface 34 of support arms 28 via a track-engaging ridge 62B formed onheat sink 36. Track 60 and track-engaging ridge 62B can have anysuitable complementary configuration and orientation to retain heat sink36 against support arms 28, and to retain light source 30 orientedtoward a wearer's face when light-therapy apparatus 20 is in the useposition. Heat sink 36 can alternatively be coupled to support arms 28in any suitable manner, rather than via engagement with track 60 throughoptional track-engaging ridge 62B. For example, heat sink 36 can becoupled to light source 30 by a clip, clamp, adhesive, thermallyconductive adhesive, hook and loop fastener, or any other connectionmechanism. In some embodiments, heat sink 36 can be integrally formedwith either or both of light source 30 or support arms 28. In someembodiments, a heat sink can be coupled to each light source.

A gas, liquid, or solid state cooling system can be provided on supportarms 28 to maintain light source 30 at a suitable temperature, orpassive cooling means can be employed as previously described. In someembodiments, the temperature of the inner surface 32 of light source 30can be maintained below a temperature of about 41° C., in oneembodiment, from about 20° C. to about 35° C. A cable recess,illustrated for example as 64A or 64B (FIGS. 7A and 7B) can be providedin light source 30 to accommodate cables for carrying electricity tolight source 30 or components of a gas or liquid cooling system. Anoptional sensor or a controller 50 as described below can be provided,to automatically switch off any light source if the temperature of innersurface 32 or some other designated portion of that particular lightsource 30 exceeds a predetermined value.

The temperature of a light source can be varied or maintained tomaintain or approach a desired temperature. For example, a coolingsystem can be used to reduce the temperature of a light source andprevent it from becoming too hot. In some situations, a temperaturecontrol system can be provided that can prevent a light source frombeing too cold or too hot. A desired temperature range can be preset.The desired temperature range can be fixed or adjustable. In someembodiments, a desired temperature range can range about ±10° C., about±7° C., about ±5° C., or about ±3° C. of the ambient air temperature, orrange about ±10° C., about ±7° C., about ±5° C., or about ±3° C. of theskin temperature of the user wearing the apparatus.

In some embodiments, light-therapy apparatus 20 is disposed andsupported exclusively or substantially external to a mouth of a patient.A light-therapy apparatus which is supported exclusively orsubstantially external to a mouth of a patient can facilitate the use ofthat light-therapy apparatus optionally with one or more of a widevariety of intra-oral orthodontic devices. For example, orthodonticappliances, such as those disclosed herein, can be provided asintra-oral orthodontic devices and employed in the present apparatusesor methods. In other embodiments, a portion of light-therapy apparatus20 can be disposed within a mouth of a patient, to assist in securing orpositioning light-therapy apparatus 20 on a patient's face or head. Forexample, bite wings or an intra-oral tray which is supported in positionby having a patient hold the intra-oral tray between her or his upperand lower teeth can be coupled to light-therapy apparatus 20 to assistin retaining or supporting the apparatus. An example of a suitableintra-oral tray is described in PCT publication numbers WO2009/000075and WO 2006/087633, both of which are incorporated by reference hereinin their entirety. In some embodiments, an intra-oral device cancomprise one or more light sources or be capable of intra-orallyadministering light to a region. In some embodiments, light can beadministered to a region intra-orally or extra-orally or both. In otherembodiments, light is administered to a region only extra-orally, and isnot administered to a region intra-orally. In some instances, light canonly be administered to a region transdermally through the skin of thepatient.

FIG. 9 shows an illustrative light-therapy apparatus 2 that comprises anextra-oral light source 4 having a right side 1 and a left side 3 (asviewed from the front of the apparatus), an extra-oral bridge 5, and anintra-oral tray 7. Intra-oral tray 7 registers to a patient's teeth. Alight source 4 is rigidly connected to intra-oral tray 7 by extra-oralbridge 5. Alternatively, some flexibility can be provided between theintra-oral tray and the extra-oral bridge. Therefore, a patient canposition a light source 4 accurately and repeatedly to illuminate adesired location in the patient's dental or maxillofacial areas byinserting intra-oral tray 7 into his or her mouth and biting intra-oraltray 7 so that it registers to at least some of the patient's teeth.This stabilizes light-therapy apparatus 2 and positions a light source 4at a desired position. The consistent alignment and targeting of lightfrom the light source 4 during subsequent treatments makes thetreatments more repeatable.

In the illustrated embodiment, extra-oral bridge 5 is removable from anextra-oral light source 4 and intra-oral tray 7. Providing alight-therapy apparatus 2 having major components that are detachablyconnectable to one another adds versatility. A design which permits themajor components of the light-therapy apparatus to be disassembled andreassembled while preserving alignment of extra-oral light source 4 tointra-oral tray 7 has the advantage that the apparatus can bedisassembled for storage or transportation and then used immediatelyafter assembly. FIG. 11 shows light-therapy apparatus 2 with extra-orallight source left side 3 detached from extra-oral bridge 5.

Extra-oral bridge 5, extra-oral light source right side 1, andextra-oral light source left side 3 can be secured together via asuitable connector. For example, extra-oral bridge 5, the extra-orallight source right side 1, and the extra-oral light source left side 3can be connected by inserting male connector portions 6A of theextra-oral light source right and left sides 1 and 3 into correspondingfemale connector portions 8A of extra-oral bridge 5 (see FIG. 11).Suitably, the suitable connector allows extra-oral light source rightand left sides 1 and 3 to be detached from extra-oral bridge 5 for easeof use and flexibility.

In some embodiments, extra-oral light source right and left sides 1 and3 are rotatable between a sagittal orientation (as shown in FIG. 9) anda vertical orientation (indicated in dotted outline in FIG. 9). Lightsource right and left sides 1 and 3 can be locked at a desired angle ofrotation by any suitable mechanism. This permits light source right andleft sides 1 and 3 to be arranged so that the light that they emit fullycovers the desired treatment areas.

Intra-oral tray 7 can be connected to extra-oral bridge 5 by way ofanother suitable connector. In the embodiment illustrated in FIG. 13, amale portion 6B of intra-oral tray 7 is removably received in a femaleportion 8B of extra-oral bridge 5. Where intra-oral tray 7 is removablefrom extra-oral bridge 5, extra-oral bridge 5 can be reused for otherpatients (after suitable sterilization). Intra-oral tray 7 can bedisposed of after it is no longer required by a patient. In someembodiments, extra-oral bridge 5 is non-removably attached to intra-oraltray 7.

Intra-oral tray 7 can be inserted into a patient's mouth and can besuitably shaped to fit around a patient's teeth. Intra-oral tray 7 canregister with a few selected teeth (for example, intra-oral tray 7 cancomprise a bite tab) or can fit around the patient's full set of teeth.In one embodiment, the intra-oral tray 7 comprises a frame of a plasticor other suitable material that can serve as a skeleton for a settablematerial. The intra-oral tray frame can be perforated to aid retentionof the settable material. The intra-oral tray frame can compriseextra-oral bridge 5 or a connector to connect to extra-oral bridge 5.The intra-oral tray can be optionally provided, and other securing meansfor an extra-oral bridge can be provided. For example, frames, asdescribed elsewhere herein, can support an extra-oral bridge orextra-oral light source relative to the patient's face.

Prior to being used in the administration of light, a frame forintra-oral tray 7 can be filled with a suitable settable material (forexample a clear vinyl siloxane gel or similar material) which setsaround the patient's teeth and subsequently allows repeatable alignmentof intra-oral tray 7 in the patient's mouth. Where intra-oral tray 7could be in the path of light as it travels from light source 4 toselected tissues, the material of intra-oral tray 7 should betransparent to the light.

Extra-oral bridge 5 can conform around the jaw line of a patient. Thelight source right and left sides 1 and 3 can be respectively positionedon the right and left sides of a patient's face along the patient's jawline. Extra-oral bridge 5 can be adjustable to permit alignment of lightsource left and right sides 1 and 3 with selected areas to beirradiated. Light source left and right sides 1 and 3 are extra-oral(outside of the patient's oral cavity). Light can pass from left andright sides 1 and 3 through tissues of the patient's lips and cheeksinto selected areas on the patient's gums or in the patient's jaws.Light can be administered transcutaneously through the patient's face toany region as disclosed herein.

In some embodiments, one or more light source 4 emits light toward thepatient. Any light source, with any configuration of light emitters asdescribed anywhere else herein can be used. In some embodiments, a lightsource 4 has an inner surface 13 (see FIG. 12) that is placed near oragainst the patient's skin adjacent to the tissues that it is desired totreat. In some embodiments, one or more light source can contact thepatient's face. The one or more light source can contact the portion ofthe face overlying a desired region. Light is emitted is from innersurface 13 toward the area of treatment. In some embodiments, left andright sides 1 and 3 of light source 4 each have a length similar to asignificant fraction of the length of a human jaw. For example, left andright sides 1 and 3 can each have a length of about 20 mm to about 90 mmin some embodiments and about 25 to about 45 mm or about 60 mm in someembodiments. A light source can have any other dimensions, includingthose disclosed herein. In cases where a light source 4 is intended totreat or prevent a localized condition, then light source 4 can besmaller in extent. In some embodiments, light source 4 has optics thatemit light in the form of diverging beams. The light source is usablewith optics as described anywhere above. In such cases, light source 4can be somewhat smaller than the area of tissues to be treated becauselight from light source 4 can diverge as it passes through the tissuesof the patient's lips and cheeks before reaching the tissues of the jawand or gums.

Light source 4 can be wide enough to irradiate both upper and lower jawsof a patient simultaneously although in some embodiments light source 4can be narrower. For example, light source 4 has a width in the range ofabout 12 mm to about 40 mm in some embodiments (e.g. about 15 to about17 mm in some embodiments). In some embodiments, a light sourceirradiates only an upper jaw or a lower jaw, or portions thereof.

While the invention is described herein as usefully employing LEDs,other light emitters such as lasers could suitably be employed. Thecharacter of the light emitted by light source right and left sides 1and 3 will depend upon the nature of the LEDs or other light emitters inlight source 4. It is generally desirable that the emitted light includelight in the wavelength range of 620 nm to 1000 nm. In some embodimentsthe emitted light includes light having a wavelength in at least one ofthe following wavelength ranges: about 820 to about 890 nm or about 620to about 680 nm. In some embodiments, light having a wavelength in theranges of about 820 to about 890 nm and about 620 to about 680 nm can beprovided. Light having wavelengths corresponding to or falling withinone or more of the following ranges can be particularly effective: about613 nm to about 624 nm, about 667 nm to about 684 nm, about 750 nm toabout 773 nm, about 812 nm to about 846 nm, or any other wavelengthsdescribed elsewhere herein. The range about 613 nm to about 624 nmcorresponds to a band at which reduced cytochrome c oxidase absorbslight. The range about 812 nm to about 846 nm corresponds to a band atwhich oxidized cytochrome c oxidase absorbs light. Light sources can beconfigured to provide light of any other wavelength as describedanywhere above.

FIGS. 14 and 15 show a light-therapy apparatus 202A having a head-setstyle arrangement. Light-therapy apparatus 202A comprises a head-set 217and at least one extra-oral light source 219 mounted to head-set 217 byway of a suitable connector 221. Head-set 217 can have the general formof a frame for eyeglasses. In the illustrated embodiment, headset 217has arms 227 that fit above and around the patient's ears and a frame229 that fits over the bridge of the patient's nose. Head-set 217 canalso include lenses (not shown). Suitably, the lenses can be made of amaterial that blocks radiation at wavelengths emitted by light source219 so that the patient's eyes are protected from the radiation. Lightsource 219 can comprise an array of LEDs or other light emitters.

When head-set 217 has been adjusted to fit an individual patient, frame229 registers with the bridge of the patient's nose and arms 227 sit onthe patient's ears. Head-set 217 is configured to sit on the patient'shead in the same way each time it is put on. Head set 217 can beadjusted for fit by adjusting arms 227 which can be made of a firm,resilient material that allows for some flexibility for a better andmore secure fit for individual users. In some embodiments, arms 227 canalso be adjusted horizontally along their axis. Frame 229 can also beadjustable, for example, by bending to allow for a better and moresecure fit. An elastic keeper such as an elastic strap can be providedto hold head-set 217 in place during use.

In the embodiment shown in FIG. 16, connector 221 permits the positionof light source 219 to be adjusted both along a horizontal axis 230A anda vertical axis 230B relative to head-set 217. A yoke 231A is mounted tohead-set 217 by screws 231B which pass through slot 231C. The positionof light source 219 in horizontal direction 230A can be adjusted byloosening screws 231B, sliding yoke 231A to a desired position alongslot 231C and retightening screws 231B. Light source 219 is connected toarms 231D of yoke 231A by screws 231E which pass through slots 231F. Thevertical position of light source 219 can be adjusted by looseningscrews 231E, sliding light source 219 up or down along slots 231F to adesired vertical position and then retightening screws 231E. Any othermechanism, including those described elsewhere herein, can be used toallow the light source position to be altered vertically orhorizontally.

In the illustrated embodiment slot 231C is curved when viewed fromabove. Slot 231C generally follows the curvature of a typical maxillarybone such that light source 219 can effectively be applied against thepatient's skin for a range of positions of light source 219 along slot231C. Since the lower portions of people's faces are typically narrowerthan upper portions, connector 221 can hold light source 219 so that itis tilted with its lower edge projecting more in the direction of thepatient than its upper edge. In some embodiments the angle of tile oflight source 219 is adjustable. Head-set 217 can be adjusted so thatlight source 19 is biased against the patient's face when head set 217is being worn by a patient. When the apparatus is in use, the lightsource can be contacting the patient's face. The light source cancontact the region of the face overlying the region, therebyadministering light transdermally to the region.

Many alternative designs for connector 221 can be provided. For example,connector 221 can comprise a bar, rod or similar device that can beclamped or otherwise fastened to head-set 217 and a clip or similarmechanism that fastens light source 219 to the bar, rod or similardevice.

As shown in FIG. 17, in some embodiments light source 219 can beremovably detached from headset 217. This can be convenient for storageor transportation of light-therapy apparatus 202A. When the apparatus isin use, the light source can contact a patient's face.

In another embodiment, head-set 217 comprises an adjustable strap (notshown) which fits around the crown of a patient's head for securing theextra-oral light-therapy apparatus 202A. The adjustable strap can alsofit around a patient's chin and extend back to the crown and around thecrown of a patient's head. The adjustable strap can be made of aflexible, elastic woven material.

FIG. 18 shows a light-therapy apparatus 234 comprising at least onelight source 235. Light source 235 comprises at least one light emitter,for example an LED array, mounted on a thin molded substrate 251 (FIG.19). More than one array of light emitters can be provided in lightsource 235. For example, the light source 235 shown in FIG. 18 has twoarrays of LEDs. Arrays 36 of light emitters can be arranged in lowerlevel 245 and an upper level 247. The upper and lower levels can beseparately controlled. The upper and lower levels respectively irradiatetissues of the upper and lower jaws. An attaching means 243 is providedfor securing the apparatus to the area of treatment.

A power source and controller, which can comprise a programmablecontroller 215 as described above, operate light source 235 to emitlight according to a desired protocol.

In the illustrative apparatus 234 shown in FIG. 18, light source 235 hasa right section 237, a center section 239 and a left section 241. Rightsection 237 and the left section 241 are respectively supported on theright and left sides of a patient's face. One or more light sources cancontact a patient's face when the apparatus is worn by the patient. Alight source 235 as shown in FIG. 18 can be supported by way of anysuitable attaching means including: a head-set 217 as described above;an intra-oral tray 7 which can comprise a full tray or one or more bitetabs as described above; an adhesive such as double-sided adhesive tape;a strap or set of straps; or supporting or attachment mechanisms.

The LED arrays can be removably attached to light source 235 by suitableconnectors 238 such as ribbon connectors or can be more permanentlyintegrated into light source 235 as illustrated in FIG. 19. Providingremovable, repositionable LED arrays on a light source 235 permits LEDarrays to be arranged on light source 235 so as to optimally illuminateselected tissues. LED arrays can be concentrated to illuminate selectedtissues while areas of light source 35 that overly non-selected tissuesdo not need to have any LED arrays.

FIG. 20 shows a cross-section of an LED array 236 of externallight-therapy apparatus 234 detached from substrate 251. A clip orsimilar attaching means 253 allows the at least one LED array 236 to bemounted onto substrate 251. Substrate 251 can serve as a heat sink asdescribed above. Substrate 251 can be made of aluminum or similar metalthat is a good heat conductor. Substrate 251 can be moldable (i.e.,flexible in one or two dimensions so that it can be formed to followcontours of a patient's face and, once formed, retains its shape).

Hinge-like members 249 can be provided between arrays 236 to allow lightsource 235 to be bent to provide a better fit around the facial area.Hinge-like member 249 can comprise a thin crease 250 or other bend lineset into the substrate material, as illustrated in FIG. 19. Hinge-likemember 249 allows the center section 239 to fit around a patient's mouthand the right section 237 and the left section 241 to fit around apatient's face.

The apparatus can be applied by fitting a support to a patient. Thesupport can comprise a head-set, intra-oral tray, a bite tab, one ormore straps, one or more nose piece, one or more ear piece, or any othersupport or attachment mechanism. When the support has been fitted sothat it can be repeatably worn by the patient one or more light sourcescan be attached to the support at locations where light from the lightsources can illuminate a treatment area.

A treatment regimen can then be established. The physician, dentist, ortherapist at her or his office or a patient at her or his home canoptionally employ the apparatus in one or more methods of the invention.

Other embodiments, configurations, components, steps, or features can beincorporated in the invention. See, e.g., U.S. Patent Publication No.2007/0248930 and U.S. Patent Publication No. 2006/0200212, which ishereby incorporated by reference in its entirety.

To calibrate light-therapy apparatus, a sensor useful for measuringreflectance (not shown) can be provided at a location that will beadjacent the skin of a patient when light-therapy apparatus is in theuse position. The sensor can measure the reflectance of light from theskin of the patient, and if the value measured is outside apredetermined range (e.g. because light-therapy apparatus has beendisplaced from a patient's head), the sensor can automatically pause atreatment or the emission of light from light source. Pausing treatmentor the emission of light if light-therapy apparatus is displaced from apatient's head can minimize the risk of accidental injury, e.g., due toexposure of a patient's eyes to light from light source.

In some embodiments, depending on a signal from the reflectance sensor,a controller can determine whether one or more light characteristic isto be maintained or adjusted (e.g., increased or decreased). Lightcharacteristics can include, but are not limited to, light intensity,light wavelength, light coherency, light range, peak wavelength ofemission, continuity, pulsing, duty cycle, frequency, duration, orwhether a light emitter is on or off.

The light source can be configured to emit light that is substantiallymonochrome in some embodiments, although this is not mandatory.Providing light emitters that emit at multiple wavelengths allows forirradiation over multiple wavelengths for greater biological activityand greater selectivity and precision in administration. The lightsource can emit incoherent light, although this is not mandatory. Insome examples, light can be provided at a single frequency, light canhave a phase that drifts quickly, pulse of light waves can have anamplitude that changes quickly, or a light wave with a broad range offrequencies can be provided. The light can be administered continuouslyor pulsed at suitable frequencies and duty cycles. The light source canbe configured to administer any of these light characteristics asdescribed anywhere above.

In some embodiments a light source emits light that includes infraredlight, and the light source also emits light that includes brightvisible light. The bright visible light deters users from looking intolight source 30 when it is operating, provides a perceptible indicationthat the apparatus is operating, and can be useful in properlypositioning the light-therapy apparatus 20. The visible light can be,but is not necessarily, in a wavelength range that is beneficial forlight therapy. In some embodiments, the ratio of the intensities of thevisible and infrared components of the light is 1 part or less visiblelight to 5 parts or more infrared light. In some embodiments, a lightsource can comprise light emitters emitting light over a range ofwavelengths. In some embodiments, the range can include wavelengths lessthan an order of magnitude. Alternatively, the range can includewavelengths emitted at one, two, three or more orders of magnitude.

FIG. 6 illustrates an example of a programmable controller 50 of a typethat can be used to control the operation of light-therapy apparatus 20.Although controller 50 is described in this exemplary embodiment asbeing programmable, it is not necessary that controller 50 beprogrammable. For example, a controller can have controls that allowvarious parameters to be set, such as light wavelength, light intensity,light pulsing, light duty cycle, light frequency, or light duration, andcan appropriately activate light emitters of one or more light sources30 in response to an appropriate signal. A controller can control lightemissions with any light characteristics, which can include thosedescribed anywhere above. Each of the light sources, e.g. light sources30A-30H shown in FIG. 2, can be regulated independently by one or morecontrollers 50. A physician, dentist, orthodontist, therapist,technician or other professional can set those controls or programcontroller 50 so that an appropriate treatment is delivered when apatient initiates delivery of the treatment. Alternatively, the patientwho is receiving the treatment might set controls. In some embodiments,the controls can include preset programs that can be suited toparticular situations. In other embodiments, one or more parameter canbe individually adjusted or entered.

In some embodiments, as shown in FIG. 6, a programmable controller canbe a handheld device. Alternatively, the programmable controller can bepart of another device or in communication with another device, such asa computer, which can include a personal computer, server computer, orlaptop computer; personal digital assistants (PDAs) such as a Palm-baseddevice or Windows CE device; phones such as cellular phones orlocation-aware portable phones (such as GPS); a roaming device, such asa network-connected roaming device; a wireless device such as a wirelessemail device or other device capable of communicating wireless with acomputer network; or any other type of network device that cancommunicate over a network. Any description herein of computers or anyother devices can apply to other devices, including controllers. Adevice can have a memory that can include tangible computer readablemedia that can include code, logic, instructions to perform any steps,calculations, algorithms, or execute programs or pre-storedinstructions.

Programmable controller 50 can be a separate, remote unit or can bedirectly connected to or integrated with a light source 30. Theprogrammable controller can connected to or integrated with any portionof the light-therapy apparatus, which can include a local controller,actuation mechanism, frame, or any other part of the controller.

A cable 52 can be provided to connect light-therapy apparatus 20 toprogrammable controller 50, a source of electricity for light source 30,or a suitable heating or cooling system. In some embodiments, wiredcommunication can be provided between the programmable controller andthe light-therapy apparatus. In other embodiments, the programmablecontroller and the light-therapy apparatus can communicate wirelessly.Examples of wireless signals can include, but are not limited to,radio-frequency (e.g., RFID) signals, bluetooth, or control-area-network(CAN) messages.

In some embodiments, controller 50 can comprise a microprocessor, datastore, power supply, clock and associated electronic circuitry. A powersource can include an external power source or an internal power source.For example, power can be provided by an electric plug. The plug mightbe in communication with a grid/utility, generator, or energy storagesystem. In some embodiments, the power source might be a renewable powersource. The power source can be an energy storage system, such as abattery, ultracapacitor, or fuel cell. In some embodiments, the powersource can be portable.

Control parameters are stored in the data store. A controller cancomprise a memory that can include tangible computer readable media thatcan include code, logic, instructions to perform any steps,calculations, algorithms, or execute programs or pre-storedinstructions. Programmable controller 50 operates light source 30according to the parameters in the data store. The parameters canspecify one or more of: treatment duration; wavelength or wavelengths oflight emitted by light emitters 38; light intensity of particularwavelength or wavelength ranges during the treatment; whether lightemitters 38 operate continuously or are pulsed; if light emitters 38 arepulsed, the rate at which light emitters 38 are pulsed; if lightemitters 38 are pulsed, the duty cycle at which light emitters 38 arepulsed, light coherency of the light emitters 38, or any other lightcharacteristic as described anywhere above. The light emitters withinthe same light source can have the same light parameters. Alternatively,there can be light emitters of different light parameters within thesame light source.

If light-therapy apparatus 20 has sets of light emitters 38 havingdifferent characteristics (e.g. sets of LEDs that emit light atdifferent wavelengths or sets of light sources 30 that illuminateselected tissues in different locations) then separate controlparameters can be provided for different sets of the light emitters 38or light sources 30. In some embodiments, different sets of parametersare specified for different segments (intervals) of a light treatment.For example, light therapy treatments can be defined for a set ofintervals each lasting from a few seconds to a few hundred seconds or afraction of an hour. Different parameters can be specified for each ofthe intervals. The intervals are not necessarily equal in length. Insome embodiments, a clock of a controller can assist in determiningwhether a predefined time interval has passed.

In some embodiments, different sets of parameters can be specified fordifferent areas of light-therapy apparatus 20. In some cases, some lightsources 30 of light-therapy apparatus 20 can be turned off because thetreatment plan for a patient does not require light of particularwavelength or light at all wavelengths to be administered at locationscorresponding to those parts of the light-therapy apparatus 20. Forexample, with reference to FIG. 2, programmable controller 50 can beprogrammed such that only light sources 30A, 30B, 30C and 30D areactivated for a particular treatment regime in which it is desired thatlight therapy be administered only to a patient's upper teeth.Alternatively, programmable controller 50 can be programmed such thatonly light sources 30A, 30D, 30E and 30H are activated for a particulartreatment regime in which it is desired that light be administered onlyto a patient's molars. Various other combinations and permutations ofthe activation of various light sources disposed about light-therapyapparatus 20 in any suitable configuration can be devised andimplemented, depending on the desired application. In some embodiments,light-therapy apparatus 20 is configured (i.e. light sources 30 arepositioned and oriented) so as to provide substantially uniformillumination of substantially the entire maxillary and mandibularalveolar bone or teeth of a patient. The light-therapy apparatus can beconfigured to provide substantially uniform illumination to otherregions of the patient. The regions can optionally be limited toalveolar bone or basal bone.

A physician, dentist, orthodontist, therapist, assistant, technician, orother professional can program a patient's treatment regimen intoprogrammable controller 50. This can be done, for example, with the aidof suitable software running on a computer that is in data communicationwith programmable controller 50 or by way of a suitable user interfacebuilt into programmable controller 50. In some embodiments, programminga treatment regimen can include specifying desired values for one ormore parameter of light treatment. Programming a treatment regiment canalso include specifying timing associated with the one or moreparameters of light treatment. For example, a treatment regimen can beprogrammed so that for the first several minutes, light is provided at afirst wavelength, and for the next several minutes, light is provided ata second wavelength. In some embodiments, default values can beprovided. A user can be able to adjust the default values to create acustomized light treatment regimen. In other embodiments, no defaultvalues are provided and a user can enter different parameter values.

Programmable controller 50 can have one or more pre-set programs builtin. As an alternative to, or as an aid to programming controller 50, thephysician, dentist, orthodontist, therapist or other professional canselect a pre-set program that is appropriate for controllinglight-therapy apparatus 20 to administer light to a patient. Suchpre-set programs can be provided for particular types or stages oforthodontic treatment. In some embodiments, a pre-set program can beselected, and a user can modify the pre-set program as desired. Forexample, a user can be able to deviate from a pre-set program byadjusting any of the following: timing, light wavelength, lightintensity, light pulsing or continuous, light duty cycle, lightfrequency, which lights are on or off, location of light source, or anyother parameter that is described elsewhere herein.

In some embodiments, a program can be determined prior to using thelight-therapy apparatus. For example, after a user has created orselected a program, the light-therapy apparatus can be used, and one ormore light source can emit light. In some embodiments, once a program isbeing implemented or a light-therapy apparatus is in use, the lighttreatment regimen is not be altered. In other embodiments, a lighttreatment regimen can be altered while the light-therapy apparatus is inuse. For example, while light is being emitted, the light intensity canbe adjusted, the light pulsing or continuous characteristics, the lightwavelength, light selection, or location of the light source relative toa patient's face can be adjusted. The treatment regimen can be adjustedvia the controller or a device in communication with the controller. Insome embodiments, a patient wearing a light-therapy apparatus can adjustthe treatment regimen. In other embodiments, physician, dentist,orthodontist, therapist, technician, assistant, or other professionalcan adjust the treatment regimen.

A user can interact with a user interface to program a controller,select a program or adjust a value of a program. Any user interfaceknown in the art can be utilized. For example, a programmable controllercan include one or more button, pointing device (e.g., mouse, joystick,trackball), keyboard, switch, knob, dial, touchscreen, or video display.The user interface can be provided to the controller directly, or can beprovided to a device (e.g., computer) that can be in communication withthe controller. A controller can include a display that can provideinformation to the user about selected parameters, timing or pre-setprograms.

Programmable controller 50 can maintain a log of treatments that havebeen administered. For example, controller 50 can log the date and timethat each treatment was initiated, the duration of the treatment, andwhether or not the treatment was completed. The date and time can belogged based on a clock associated with the programmable controller. Oneor more timestamp can be provided indicating timing. The log canindicate parameters associated with the treatment. The log can be storedwithin a memory of the programmable controller. Alternatively, the logcan be stored within a memory of a device in communication with theprogrammable controller, such as a computer.

The log can be accessed by a user to view log data. In one embodiment,the log can be accessed by a dentist, physician, orthodontist,technician, or patient who uses the light-therapy apparatus. A user canaccess the log directly from a controller or a device in communicationwith the controller. A user can access the log from any device that canbe in communication with a device that stores the log data. Thecontroller or devices can communicate directly with one another or overa network. The network can include a local area network, or a wide areanetwork, such as the Internet.

This log can be subsequently reviewed by a dentist, physician,orthodontist or other medical professional to evaluate whether or notthe patient has complied with a prescribed treatment regimen. The logcan be displayed to a screen or other video display of a device. The logcan track the times and durations of light therapy treatmentsadministered by light-therapy apparatus 20 and can also track otherfeatures such as operating temperatures, operational status, treatmentparameters, timing, or any combination thereof.

In some embodiments, a programmable controller 50 has a button or othersuitable user patient interface that allows a patient to initiate atreatment according to previously-set parameters in the data store. Insome embodiments, the patient interface is very simple such that minimalinstruction is required to explain to a patient how to use light-therapyapparatus 20. Programmable controller 50 can include an audible orvisual indicator that generates a signal to remind a patient that it istime for a treatment (or that a scheduled treatment is overdue).

In some embodiments, a treatment regimen can be pre-selected orprogrammed at the same device (e.g., controller, computer) through whicha patient can initiate a treatment. Alternatively, a treatment regimencan be pre-selected or programmed at a different device (e.g.,controller, computer) through which a patient can initiate a treatment.In some embodiments, communications can be provided between thecontroller and another device (e.g., computer) that can allow one ormore treatment program to be delivered to the controller. In someembodiments, two-way communications can be provided between thecontroller and another device. In other embodiments, one-waycommunications can be provided from the other device to the controlleror vice versa.

A patient can use light-therapy apparatus 20 at home or in anotherlocation by operating programmable controller 50 to initiate delivery ofa treatment. The patient can use the light-therapy apparatus while at anappointment with a medical professional, or at a laboratory or clinic.Alternatively, a patient can use this apparatus while not at anappointment with a medical professional, or at a laboratory or clinic.The patient can use this apparatus while the patient is mobile ortraveling.

Programmable controller 50 can comprise circuitry that monitorstemperature at one or more locations in light source 30. The circuitrycan monitor a signal modulated by a temperature sensor in light source30. In some embodiments, the temperature sensor can be a thermocouple,thermistor, or resistance temperature sensor (RTD). In otherembodiments, programmable controller 50 can monitor e.g. the current andvoltage driving light emitters (e.g., LEDs, lasers) in light source 30.The current/voltage relationship can be temperature-dependent. Thus, bymonitoring the current/voltage relationship programmable controller 50can determine whether the light emitter (e.g., LED, laser) is at anundesirably high temperature. A temperature sensor can also be used todetermine whether a light source or light assembly, or any componentthereof is at an undesirably high temperature. Furthermore, thetemperature sensor can determine whether a light emitter, light source,or light assembly has an undesirably low temperature. A temperaturesensor can be used to determine whether any part of a light-therapyapparatus falls within a desired temperature range.

Programmable controller 50 can shut off or reduce current to anyparticular light source (e.g. one or more of light sources 30A-30H) whenit detects that the temperature of that light source is undesirably high(or is trending towards being undesirably high). The programmablecontroller can also shut off or reduce current to any particular lightemitter (e.g., one or more light emitter can be provided for a lightsource) if the controller detects that the temperature at that lightemitter is undesirably high. Alternatively, the programmable controllercan shut off or reduce current to a group or subgroups of light emittersor light sources if the temperature of a particular light emitter orlight source is too high. For example, the programmable controller canshut off or reduce current to all light sources if a temperature is toohigh.

If light-therapy apparatus 20 is provided with a cooling apparatus,controller 50 can increase the operation of the cooling apparatus whenit detects that the temperature of light source 30 is above a desiredlevel. If increasing operation of the cooling apparatus does not bringthe temperature of a light source or light emitter or any other portionof a light-therapy apparatus to a desired level, one or more lightemitters or light sources can be shut off or reduced.

Shut-off or current reducing steps can occur automatically when atemperature threshold is reached. In some embodiments, a user can definethe temperature threshold. In other embodiments the temperaturethreshold can be pre-set. In some embodiments, an alarm or alert can beprovided when a temperature threshold is reached, and a user canmanually shut off or reduce current to a light source or light emitter.In some embodiments, a temperature measurement can be displayed to auser.

Another aspect of the invention further provides for a light therapy kitcomprising a light-therapy apparatus as described herein andinstructions for use in the present methods. The kit can furthercomprise a light source that is separate from the light-therapyapparatus. The light sources can be disposable, so that they can beeasily replaced after a given amount of use. In some embodiments, alight-therapy apparatus and light sources can be individually packagedor can be packaged together.

The kit can also comprise a programmable controller as described herein.The kit can further comprise any components useful for the controller tooperate. For example, the kit can comprise a component to power thecontroller or light-therapy apparatus. The kit can also comprise acomponent that allows the controller to operably connect with alight-therapy apparatus.

The kit can also comprise software, an algorithm, or a set of computerreadable media that can provide instructions to a controller. Thesoftware, algorithm, or set of computer readable media can be providedon a memory medium. The memory medium can be a removable or portable,such as a CD, USB flash drive, or external hard drive.

The kit can be conveniently packaged and can be commercially available.The kit can also include written instructions for use or maintenance ofitems therein.

In use, a physician, dentist, orthodontist, therapist or otherprofessional can program a patient's prescribed treatment regimen into aprogrammable controller 50 (see FIG. 6, for example). Programmablecontroller 50 controls parameters of a light therapy treatment to beadministered by light-therapy apparatus 20. For example, controller 50can control the duration of the treatment, wavelength or wavelengths oflight administered, light intensity, pulse frequency, or any other lightor treatment characteristics. Programmable controller 50 runs apatient's prescribed treatment regimen causing the at least one lightsource 30 to emit pulsed or continuous light of specified wavelengthsaccording to the prescribed parameters onto the treatment area of apatient's maxillary or mandibular alveolar bone. The treatment area caninclude any other regions described elsewhere herein. This can includealveolar bone, basal bone, or teeth. Light can be administered mostlyonly to the treatment area. Light-therapy apparatus 20 can provideeffective, stabilized repeatable, accurate, programmable, and consistentlight therapy for a desired treatment to specifically administer lightof a desired wavelength or wavelengths to a particular treatment regionat a substantially uniform intensity. Scattering of light as it enters apatient's soft tissues can also cause the beam of light to diverge,resulting in uniform illumination of the patient's soft or hard tissue.

In accordance with another aspect of the invention, a light-therapyapparatus can be used in a method of administering light to a region ofa patient's oral tissue. The method can include providing alight-therapy apparatus comprising a support sized and shaped to engagewith features of the patient's face and one or more light sourcesupported by the support, engaging the support with one or more featuresof the patient's face, determining whether the position of one or morelight source needs to be adjusted in order to administer a desiredintensity of light to the region, depending on said determination,varying or maintaining the position of the one or more light source, andadministering light to the region.

The light-therapy apparatus can optionally be an apparatus as describedin any of the embodiments anywhere above. The light-therapy apparatuscan include a support that can be engaged with one or more features ofthe patient's face. For example, the light-therapy apparatus can engagewith features of a patient's face by conforming to the shape of thefeature, wrapping around the feature, overlying the feature, graspingthe feature, adhering to the feature or providing pressure or weight tothe feature. For example, the light-therapy apparatus can include anear-engaging portion that can wrap around the back of the patient's ear.In another embodiment, the light-therapy apparatus can include anose-engaging portion that can rest on the bridge of the patient's nose.

A method for administering light to a region can also includedetermining whether the position of one or more light source needs to beadjusted in order to administer a desired intensity of light to theregion. Such determination can be made manually or automatically. Forexample, the patient or a medical professional can determine theposition of a light source when the light-therapy apparatus is worn. Thepatient or medical professional can determine the relative position ofthe light source to a desired region. The light-therapy apparatuscomprises one or more sensor. In some embodiments, the sensor can be atemperature sensor or a reflectance sensor. In another embodiment, asensor can determine the relative position of the light source withrespect to the region. Determining whether a light characteristic needsto be adjusted in order to administer a desired light to the region canbe based on one or more signal from the one or more sensor.

Depending on said determination, the position of the one or more lightsource can be varied or maintained. The position of the light can bevaried manually or automatically. For example, a patient or medicalprofessional can manually move a light source. In another embodiment,one or more actuator can be provided in communication with a controller.The controller can provide one or more signal to the actuator, therebycausing the actuator to move or maintain its position. The light sourcecan be displaced, rotated, or tilted to provide a desired intensity oflight to a region. In some instances, the light source can be pressedagainst the patient's face above the region, and the position of thelight source can be set to that location. In some embodiments, after theposition of a light source is adjusted, the light source can remain atthat position in the absence of any outside force. In some embodiments,a light source can be locked into a position after it is adjusted, sothat the light source can remain in that position even if a force isexerted on it.

In some embodiments, after a light has been set to a desired position,the method can include administering light to the region. In some otherembodiments, light can be administered before or while the light isbeing set to a desired position. In some embodiments, a light-therapyapparatus can be engaged with the patient, the light source can bepositioned, and the light can be administered without removing thelight-therapy apparatus from the patient. In some embodiments, thelight-therapy apparatus can be engaged with the patient, the lightsource can be positioned, and the light-therapy apparatus can be removedfrom the patient. This can be a series of steps for fitting thelight-therapy apparatus to the patient. The light-therapy apparatus cansubsequently be re-engaged with the patient and light can beadministered to the patient. This can include steps for administeringthe light to the patient, after fitting the light-therapy apparatus tothe patient. The light sources can already be positioned to administerlight to the region. In some instances, light can be administered to thepatient on multiple occasions following a single fitting.

In some embodiments, the method can include varying the position of oneor more light source by adjusting the position of the light along thelength of the support. The method the method can also include varyingthe position of one or more light by rotating the light source about anaxis. The axis can be vertical, horizontal, or provided at any otherorientation.

In some embodiments, light therapy apparatuses may be provided which areparticularly suitable for intra-oral administration of light to one ormore regions within a patient's oral cavity or mouth, such as a regionof the patient's maxillary or mandibular alveolar bone. An intra-orallight therapy apparatus may incorporate one or more features orcomponents of one or more embodiment of a light source or light therapyapparatus described herein. In one embodiment an intra-oral lighttherapy apparatus irradiates light having one or more characteristics oflight described above.

Examples of intra-oral light therapy devices can include a laser beamdelivered by an optical fiber to a point of irradiation. In oneembodiment, a low-energy laser source, such as agallium-aluminum-arsenide laser can be used. See, e.g., Kawasaki, etal., “Effects of Low-Energy Laser Irradiation on Bone Remodeling DuringExperimental Tooth Movement in Rats,” Lasers in Surgery and Medicine26:282-291 (2000); Cruz, et al., “Effects of Low-Intensity Laser Therapyon the Orthodontic Movement Velocity of Human Teeth: A PreliminaryStudy,” Lasers in Surgery and Medicine 35: 117-120 (2004); Abi-Ramia, etal., “Effects of Low-Level Laser Therapy and Orthodontic Tooth Movementon Dental Pulp in Rats,” Angle Orthodontist, 80(1): 116-122 (2010),which are hereby incorporated by reference in their entirety.

Other examples of intra-oral light therapy devices can include an oraltray that fits over one or more tooth or gums. In another embodiment, anoral tray need not fit over one or more tooth, but may be contoured tofit within a patient's oral cavity. Light from a light source can betransmitted to one or more teeth, or gum or mucosal tissue overlying oneor more tooth root, via the oral tray. In some embodiments, the trayreflects or conveys light from a natural source (e.g., sun) or man-madesource (e.g., lasers, LEDs, or light sources having any of thecharacteristics previously mentioned). In some embodiments, a lightsource is embedded within the tray or attached to the tray. In otherembodiments, the intra-oral therapy devices include a cap-like structurethat can fit over one or more tooth, or gum or mucosal tissue overlyingone or more tooth root. The cap-light structure can transmit light froma distal light source. Alternatively, the cap-like structure comprises alight source provided therein. In some embodiments, the intra-oral lighttherapy devices are handheld devices that can provide or direct light toone or more tooth, or gum or mucosal tissue overlying one or more toothroot. The light can be provided from a proximal or distal light source.In some embodiments, the handheld devices comprise or otherwise utilizefiberoptics. The light-providing portion of the handheld device can beheld adjacent to a tooth, gums, or mucosal tissue overlying a toothroot. In some instances, the light providing portion of the handhelddevice can be located within a patient's oral cavity. See, e.g., U.S.Pat. No. 2,884,926; U.S. Patent Publication No. 2008/0255498; U.S.Patent Application No. 2006/0085052; U.S. Patent Publication No.2008/0032252, which are hereby incorporated by reference in theirentirety.

In some embodiments, a light therapy apparatus as described above isuseful for administering light intra-orally. Thus, a light therapyapparatus can be configured to provide light extra-orally orintra-orally or both. An intra-oral light therapy apparatus may be usedin conjunction with an extra-oral light therapy apparatus as describedabove.

EXAMPLE

The invention is further described with reference to the followingspecific examples, which are not meant to limit the invention, butrather to further illustrate it.

A patient presents with an upper right first and second molar that havedrifted forward due to a congenitally missing second bicuspid. Thepatient would benefit from having her teeth distalized. While atemporary orthodontic device (TAD) anchorage with an implant could beused to exert force to retract these teeth, heavy forces, without more,can cause the implant to fail prematurely.

The implant is installed, and light having a wavelength of about 850 nmand intensity of 70 mW/cm² is administered to the implant and to themandibular and maxillary alveolar bone surrounding the first and secondmolars only. The teeth and implant are pretreated with light for 10minutes immediately prior to the activation of the TAD anchorageappliance, which administers a force of about 300 grams to the teeth(about 150 grams of force exerted per tooth). Light treatment occurs foran additional 10 minutes immediately following the activation of theappliance. Light is administered daily for about 20 minutes for about2-3 weeks following the activation of the appliance. It is believed thatnot only would the two teeth be distalized, but the administration oflight would prevent the loosening and resorption of the bone around theTAD. The heavy forces would allow the 2 molars to distalize without therisk of causing resorption of the teeth roots as well as counter theocclusal forces that tend to prevent distalizing of posterior teeth.

While particular embodiments of the present invention have been shownand described herein, such embodiments are provided by way of exampleonly. Numerous variations, changes, and substitutions will now occur tothose skilled in the art without departing from the invention. It shouldbe understood that various alternatives to the embodiments of theinvention described herein can be employed in practicing the invention.It is intended that the following claims define the scope of theinvention and that methods and structures within the scope of theseclaims and their equivalents be covered thereby.

What is claimed is:
 1. A method for regulating tooth movement,comprising: (a) allowing a heavy force to be exerted on one or moreteeth of a patient in need thereof; and (b) administering an effectiveamount of light to the maxillary or mandibular alveolar bone of thepatient, wherein the light is administered before, during, or after theheavy force is exerted.
 2. The method of claim 1, wherein the heavyforce has a magnitude ranging from about 175 grams of force to about 500grams of force.
 3. The method of claim 1, wherein the patient has anorthodontic appliance on one or more of the patient's teeth.
 4. Themethod of claim 3, wherein the orthodontic appliance exerts the heavyforce to the one or more teeth.
 5. The method of claim 1, wherein thelight is extra-orally administered to the maxillary or mandibularalveolar bone.
 6. The method of claim 1, wherein the light isintra-orally administered to the maxillary or mandibular bone.
 7. Themethod of claim 1, wherein the light has a wavelength of from about 585nm to about 665 nm or from about 815 nm to about 895 nm.
 8. The methodof claim 1, further comprising installing an orthodontic appliance onone or more of the patient's teeth.
 9. The method of claim 8, whereininstalling the orthodontic appliance occurs prior to administering thelight.
 10. The method of claim 8, wherein installing the orthodonticappliance occurs subsequent to administering the light.
 11. The methodof claim 1, wherein the method further comprises removing an orthodonticappliance from one or more of the patient's teeth.
 12. The method ofclaim 1, wherein the light is substantially monochrome.
 13. The methodof claim 1, wherein the light radiates from a plurality of light sourcesthat contact the patient's face.
 14. The method of claim 1, whereinregulating tooth movement comprises increasing the velocity of toothmovement.